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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: Change from Baseline to 7-14 days after 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: Change from Baseline to 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 ofinsomnia. 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: Change Score from Baseline to 6-month Follow-Up 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.

Other outcomes

  1. Hip-Knee Injury and Osteoarthritis Outcome Score - Pain

    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. Knee injury and Osteoarthritis Outcome Score (KOOS, knee patients) / Hip disability and Osteoarthritis Outcome Score (HOOS, hip patients) - Pain subscale, assessing the frequency and severity of joint pain. Items are rated on a 5-point Likert scale (None, Mild, Moderate, Severe, Extreme) and the Pain subscale is normalized to a total score from 0 to 100, where 0 = extreme pain/problems and 100 = no pain/problems. Higher scores indicate a better outcome (less pain).

  2. 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'.

  3. 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'.

  4. 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'.

  5. 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'.

  6. 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'.

  7. 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'.

  8. 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'.

  9. 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'.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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'.

  19. 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'.

  20. 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'.

  21. 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'.

  22. 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'.

  23. 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'.

  24. 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'.

  25. 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'.

  26. 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'.

  27. 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'.

  28. 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'.

  29. 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'.

  30. 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).

  31. 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).

  32. 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)

  33. 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)

  34. 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)

  35. 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)

  36. 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)

  37. 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)

  38. 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)

  39. 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)

  40. 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)

  41. 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)

  42. 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)

  43. 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)

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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).

  49. 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

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: HH

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2020
Registry last updated
Sep 1, 2026

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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