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Completed

NCT Number: NCT04269239

Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch, Galveston, Texas, United States

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About this study

Improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), post-hospital, post-intervention and at a 6 month follow-up visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty.
  • The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment).
  • Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders.
  • Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI).
  • Referral and attendance of medical rehabilitation post-discharge.

Exclusion criteria

  • Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year).
  • Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded).
  • Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk.
  • Cognitive impairment defined as <20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of <24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.

Treatment and study plan

Healthy Habits

Behavioral

Participants in this group will be coached during four hour-long sessions on topics such as physical activity, nutrition, pain coping skills, bladder health, diabetes, heart health, eyes/vision, hearing, and doctor-patient communication.

Sleep Habits

Behavioral

Participants in this group will be coached during four hour-long sessions on topics such as sleep education, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, and relapse prevention.

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 7-14 days before scheduled surgery

    ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.

  2. Insomnia Severity Index (ISI)

    Time frame: 7-14 days after hospital discharge

    ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.

  3. Insomnia Severity Index (ISI)

    Time frame: 7-14 days after completing the 8 week intervention period

    ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.

  4. Insomnia Severity Index (ISI)

    Time frame: 6 months after completing the intervention

    ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.

  5. Wrist actigraphy

    Time frame: 7-14 days before scheduled surgery

    A wearable device will be used to measure participant sleep over seven days.

  6. Wrist actigraphy

    Time frame: 7-14 days after hospital discharge

    A wearable device will be used to measure participant sleep over seven days.

  7. Wrist actigraphy

    Time frame: 7-14 days after completing the 8 week intervention period

    A wearable device will be used to measure participant sleep over seven days.

  8. Wrist actigraphy

    Time frame: 6 months after completing the intervention

    A wearable device will be used to measure participant sleep over seven days.

Secondary outcomes

  1. PROMIS Physical Function (short form)

    Time frame: 7-14 days before scheduled surgery

    The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'

  2. PROMIS Physical Function (short form)

    Time frame: 7-14 days after hospital discharge

    The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'

  3. PROMIS Physical Function (short form)

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'

  4. PROMIS Physical Function (short form)

    Time frame: 6 months after completing the intervention

    The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'

  5. PROMIS Mobility

    Time frame: 7-14 days before scheduled surgery

    The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.

  6. PROMIS Mobility

    Time frame: 7-14 days after hospital discharge

    The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.

  7. PROMIS Mobility

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.

  8. PROMIS Mobility

    Time frame: 6 months after completing the intervention

    The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.

  9. Short Physical Performance Battery (SPPB ) motor

    Time frame: 7-14 days before scheduled surgery

    The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.

  10. Short Physical Performance Battery (SPPB ) motor

    Time frame: 7-14 days after hospital discharge

    The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.

  11. Short Physical Performance Battery (SPPB ) motor

    Time frame: 7-14 days after completing the 8 week intervention period

    The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.

  12. Short Physical Performance Battery (SPPB ) motor

    Time frame: 6 months after completing the intervention

    The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.

  13. PROMIS Applied Cognitive Abilities

    Time frame: 7-14 days before scheduled surgery

    The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.

  14. PROMIS Applied Cognitive Abilities

    Time frame: 7-14 days after hospital discharge

    The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.

  15. PROMIS Applied Cognitive Abilities

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.

  16. PROMIS Applied Cognitive Abilities

    Time frame: 6 months after completing the intervention

    The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.

  17. PROMIS Applied Cognitive Abilities- General Concerns

    Time frame: 7-14 days before scheduled surgery

    The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.

  18. PROMIS Applied Cognitive Abilities- General Concerns

    Time frame: 7-14 days after hospital discharge

    The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.

  19. PROMIS Applied Cognitive Abilities- General Concerns

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.

  20. PROMIS Applied Cognitive Abilities - General Concerns

    Time frame: 6 months after completing the intervention

    The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.

  21. Tele-neuropsychology (T-NP) Battery

    Time frame: 7-14 days before scheduled surgery

    The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall) Cognition tests will be scored.

  22. Tele-neuropsychology (T-NP) Battery

    Time frame: 7-14 days after hospital discharge

    The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.

  23. Tele-neuropsychology (T-NP) Battery

    Time frame: 7-14 days after completing the 8 week intervention period

    The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.

  24. Tele-neuropsychology (T-NP) Battery

    Time frame: 6 months after completing the intervention

    The TNP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.

  25. Activities of Daily Living (ADLs)

    Time frame: 7-14 days before scheduled surgery

    The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"

  26. Activities of Daily Living (ADLs)

    Time frame: 7-14 days after hospital discharge

    The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"

  27. Activities of Daily Living (ADLs)

    Time frame: 7-14 days after completing the 8 week intervention period

    The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"

  28. Activities of Daily Living (ADLs)

    Time frame: 6 months after completing the intervention

    The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"

  29. Instrumental ADLs (IADL) scale

    Time frame: 7-14 days before scheduled surgery

    The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.

  30. Instrumental ADLs (IADL) scale

    Time frame: 7-14 days after hospital discharge

    The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.

  31. Instrumental ADLs (IADL) scale

    Time frame: 7-14 days after completing the 8 week intervention period and

    The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.

  32. Instrumental ADLs (IADL) scale

    Time frame: 6 months after completing the intervention

    The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.

  33. Sleep Diary

    Time frame: 7-14 days before scheduled surgery

    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  34. Sleep Diary

    Time frame: 7-14 days after hospital discharge

    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  35. Sleep Diary

    Time frame: During the 8 week intervention

    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  36. Sleep Diary

    Time frame: 7-14 days after completing the 8 week intervention period

    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  37. Sleep Diary

    Time frame: 6 months after completing the intervention

    The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.

  38. Knee injury and osteoarthritis outcome score (KOOS)

    Time frame: 7-14 days before scheduled surgery

    This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.

  39. Knee injury and osteoarthritis outcome score (KOOS)

    Time frame: 6 months after completing intervention

    This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.

  40. Hip disability and osteoarthritis outcome score (HOOS)

    Time frame: 7-14 days before scheduled surgery

    This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.

  41. Hip disability and osteoarthritis outcome score (HOOS)

    Time frame: 6 months after completing intervention

    This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.

  42. StepWatch

    Time frame: 7-14 days before scheduled surgery

    A wearable device will measure physical activity over a seven day period.

  43. StepWatch

    Time frame: 7-14 days after hospital discharge

    A wearable device will measure physical activity over a seven day period.

  44. StepWatch

    Time frame: 7-14 days after completing the 8 week intervention period

    A wearable device will measure physical activity over a seven day period.

  45. StepWatch

    Time frame: 6 months after completing the intervention

    A wearable device will measure physical activity over a seven day period.

Other outcomes

  1. PROMIS Pain Intensity

    Time frame: 7-14 days before scheduled surgery

    The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.

  2. PROMIS Pain Intensity

    Time frame: 7-14 days after hospital discharge

    The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.

  3. PROMIS Pain Intensity

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.

  4. PROMIS Pain Intensity

    Time frame: 6 months after completing the intervention

    The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.

  5. PROMIS Pain Interference

    Time frame: 7-14 days before schedule surgery

    The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.

  6. PROMIS Pain Interference

    Time frame: 7-14 days after hospital discharge

    The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.

  7. PROMIS Pain Interference

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.

  8. PROMIS Pain Interference

    Time frame: 6 months after completing the intervention

    The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.

  9. PROMIS Fatigue

    Time frame: 7-14 days before scheduled surgery

    The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.

  10. PROMIS Fatigue

    Time frame: 7-14 days after hospital discharge

    The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.

  11. PROMIS Fatigue

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.

  12. PROMIS Fatigue

    Time frame: 6 months after completing the intervention

    The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.

  13. PROMIS Emotional Distress-Depressesion

    Time frame: 7-14 days before scheduled surgery

    The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.

  14. PROMIS Emotional Distress-Depressesion

    Time frame: 7-14 days after hospital discharge

    The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.

  15. PROMIS Emotional Distress-Depressesion

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.

  16. PROMIS Emotional Distress-Depressesion

    Time frame: 6 months after completing the intervention

    The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.

  17. PROMIS Psychosocial Illness Impact - Negative

    Time frame: 7-14 days before scheduled surgery

    The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.

  18. PROMIS Psychosocial Illness Impact - Negative

    Time frame: 7-14 days after hospital discharge

    The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.

  19. PROMIS Psychosocial Illness Impact - Negative

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.

  20. PROMIS Psychosocial Illness Impact - Negative

    Time frame: 6 months after completing the intervention

    The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.

  21. PROMIS Satisfaction with Social Roles and Activities

    Time frame: 7-14 days before scheduled surgery

    The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.

  22. PROMIS Satisfaction with Social Roles and Activities

    Time frame: 7-14 days after hospital discharge

    The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.

  23. PROMIS Satisfaction with Social Roles and Activities

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.

  24. PROMIS Satisfaction with Social Roles and Activities

    Time frame: 6 months after completing the intervention

    The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.

  25. PROMIS Ability to Participate in Social Roles and Activity

    Time frame: 7-14 days before scheduled surgery

    The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.

  26. PROMIS Ability to Participate in Social Roles and Activity

    Time frame: 7-14 days after hospital discharge

    The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.

  27. PROMIS Ability to Participate in Social Roles and Activity

    Time frame: 7-14 days after completing the 8 week intervention period

    The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.

  28. PROMIS Ability to Participate in Social Roles and Activity

    Time frame: 6 months after completing the intervention

    The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.

  29. Rehabilitation Attendance

    Time frame: From hospital discharge until subject notifies study staff they have stopped attending, on average around 12 weeks.

    Weekly rehabilitation attendance will be measured via patient self-report.

  30. Plasma IL-6

    Time frame: 7-14 days before scheduled surgery

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).

  31. Plasma IL-6

    Time frame: 7-14 days after hospital discharge

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).

  32. Plasma IL-6

    Time frame: 7-14 days after completing the 8 week intervention period

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).

  33. Plasma IL-6

    Time frame: 6 months after completing the intervention

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).

  34. Plasma CRP

    Time frame: 7-14 days before scheduled surgery

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)

  35. Plasma CRP

    Time frame: 7-14 days after hospital discharge

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)

  36. Plasma CRP

    Time frame: 7-14 days after completing the 8 week intervention period

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)

  37. Plasma CRP

    Time frame: 6 months after completing the intervention

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)

  38. Plasma VWF

    Time frame: 7-14 days before scheduled surgery

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)

  39. Plasma VWF

    Time frame: 7-14 days after hospital discharge

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)

  40. Plasma VWF

    Time frame: 7-14 days after completing the 8 week intervention period

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)

  41. Plasma VWF

    Time frame: 6 months after completing the intervention

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)

  42. Plasma TNFalpha

    Time frame: 7-14 days before scheduled surgery

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)

  43. Plasma TNFalpha

    Time frame: 7-14 days after hospital discharge

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)

  44. Plasma TNFalpha

    Time frame: 7-14 days after completing the 8 week intervention period

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)

  45. Plasma TNFalpha

    Time frame: 6 months after completing the intervention

    Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)

  46. Medication Monitoring Form

    Time frame: 7-14 days before schedule surgery

    Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.

  47. Medication Monitoring Form

    Time frame: 7-14 days after hospital discharge

    Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.

  48. Medication Monitoring Form

    Time frame: 7-14 days after completing the 8 week intervention period

    Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.

  49. Medication Monitoring Form

    Time frame: 6 months after completing the intervention

    Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.

  50. Treatment Expectation Questionnaire

    Time frame: Immediately prior to beginning the intervention

    This questionnaire 8-question measure provided before treatment. It will be used to collect information on participants' reasons for treatment as well as their expectations of treatment (e.g., its effectiveness, the amount of effort it will take, confidence in their doctor). Participant will mark answers to each question on a visual analog scale (e.g., from Not Confident at all to Very Confident).

  51. Treatment Satisfaction Questionnaire

    Time frame: Immediately following the completion of the intervention

    Treatment Satisfaction Scale is a 10-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Acronym: HH

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2020
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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