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Completed

NCT Number: NCT04977362

Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery

Valvular heart diseases are among the most common cardiac pathologies in adult patients in Germany. Currently, the process of care before, during and after heart valve surgery does not follow a standardized and interdisciplinary optimal approach. An approach already established in other surgical disciplines is the Enhanced Recovery After Surgery (ERAS) protocol, which aims at optimizing the recovery process of patients. Within the INCREASE study, a care process inspired by the ERAS protocol will be established at the University Heart and Vascular Center (UHZ) of the University Medical Center Hamburg-Eppendorf (UKE) and the University Medical Center Augsburg (UKA). Executing the study at two facilities in different regions in Germany will help to demonstrate transferability of the process of care. The effectiveness of this process compared to the current treatment approach will be investigated in a randomized controlled trial. A total of 186 patients will be allocated by chance either to the intervention group (ERAS protocol) or the control group (treatment as usual). Patients in the intervention group will receive an optimized interdisciplinary care protocol including medical, nursing, physiotherapeutical and psychotherapeutical interventions. Measurements of effectiveness are the number of hospitalized days (due to cardiac causes) within one year and the physical condition of the patient as measured by the 6-minute walk test (6MWT) on the day of discharge.

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Key information

Conditions

Heart Valve Diseases Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Augsburg, Augsburg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for elective minimally invasive (open) aortic or mitral valve surgery
  • Patient's ability to understand the nature and extent of the individual's requirements for participation in the new care setting
  • Classification of the patient as "FIT" or "Pre-FRAIL" using the LUCAS functional index (frailty index) (Dapp et al. 2012)

Exclusion criteria

  • Limited life expectancy less than one year (e.g., advanced tumor disease)
  • Urgent or emergency interventions
  • Severe chronic obstructive pulmonary disease (GOLD III or IV)
  • Dialysis-dependant renal failure
  • Advanced liver cirrhosis (Child stages B + C)
  • Severe comorbidities or psychosocial reasons that militate against participation or do not allow for written informed consent (e. g., residual neurological impairment after prior stroke, major restrictions of mobility, neuropsychological disorders, depressive disorder, substance-related addictive disorders)
  • Lack of a social environment that can provide supportive patient care
  • Previous cardiac surgery (i.e., relative contraindication for minimally invasive technique)

Treatment and study plan

Enhanced recovery after surgery

Other

Enhanced recovery after surgery is a multimodal, transdisciplinary care approach for patients undergoing surgical procedures. It is implemented in various surgical specialties, among others in cardiac surgery. The care approach aims at promotion of recovery of the patients throughout their perioperative process, reduction of complications, and early return to normal activities.

Other names: fast track, rapid recovery, ERAS

Treatment as Usual

Other

treatment as usual according to standard care in heart valve surgery

Primary outcomes

  1. Hospitalization

    Time frame: twelve months

    number of hospitalized days due to cardiac reasons

  2. Six Minute Walk Test

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    physical capacity expressed with the walking distance in meters

Secondary outcomes

  1. Goal Attainment Scale (GAS)

    Time frame: three months

    level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected

  2. Goal Attainment Scale (GAS)

    Time frame: twelve months

    level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected

  3. HeartQoL

    Time frame: three months

    health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life

  4. HeartQoL

    Time frame: twelve months

    health-related quality of life; 14 items, min 0, max 42, higher scores indicating better health-related quality of life

  5. Costs

    Time frame: up to 10 days

    direct costs in € associated with the operative procedure and the initial hospitalization using diagnosis related groups as classification system, in which diagnoses and treatments are valued according to their necessary economical expenditure

Other outcomes

  1. European Health Literacy Questionnaire (HLS-EU-Q16)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy

  2. European Health Literacy Questionnaire (HLS-EU-Q16)

    Time frame: twelve months

    health literacy: 16 items, min 16, max 64, higher scores indicating lower health literacy

  3. Brief Illnness Perception Questionnaire (BIPQ)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    individual concept of illness; 8 items, min 0, max 80, higher scores indicating worse illness perception

  4. Brief Illnness Perception Questionnaire (BIPQ)

    Time frame: twelve months

    individual concept of illness; 8 items, min 0, max 80, higher scores indicating worse illness perception

  5. Treatment Expectation Questionnaire (TEX-Q)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment

  6. Treatment Expectation Questionnaire (TEX-Q)

    Time frame: three months

    treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment

  7. Treatment Expectation Questionnaire (TEX-Q)

    Time frame: twelve months

    treatment expectations; 15 items, min 0, max 150, higher scores indicating higher expectations of effects of the treatment

  8. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms

  9. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: three months

    depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms

  10. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: twelve months

    depressive symptoms; 9 items, min 0, max 27, higher scores indicating higher depressive symptoms

  11. Generalized Anxiety Disorder-2 (GAD-2)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms

  12. Generalized Anxiety Disorder-2 (GAD-2)

    Time frame: three months

    anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms

  13. Generalized Anxiety Disorder-2 (GAD-2)

    Time frame: twelve months

    anxiety symptoms; 2 items, min 0, max 6, higher scores indicating higher anxiety symptoms

  14. Cardiac Anxiety Questionnaire (CAQ)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety

  15. Cardiac Anxiety Questionnaire (CAQ)

    Time frame: three months

    cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety

  16. Cardiac Anxiety Questionnaire (CAQ)

    Time frame: twelve months

    cardiac anxiety; 17 items, min 0, max 68, higher scores indicating higher cardiac anxiety

  17. Life Orientation Test - revised (LOT-R)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    optimism; 10 items, min 0, max 24, higher scores indicating higher optimism

  18. Somatic Symptom Scale-8 (SSS-8)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden

  19. Somatic Symptom Scale-8 (SSS-8)

    Time frame: three months

    somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden

  20. Somatic Symptom Scale-8 (SSS-8)

    Time frame: twelve months

    somatic symptom burden; 8 items, min 0, max 32, higher scores indicating higher somatic symptom burden

  21. Somatic Symptom Disorder - B Criteria Scale (SSD-12)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms

  22. Somatic Symptom Disorder - B Criteria Scale (SSD-12)

    Time frame: three months

    coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms

  23. Somatic Symptom Disorder - B Criteria Scale (SSD-12)

    Time frame: twelve months

    coping with somatic symptoms; 12 items, min 0, max 48, higher scores indicating worse coping with somatic symptoms

  24. International Physical Activity Questionnaire Short Form (IPAQ)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    level of physical activity

  25. International Physical Activity Questionnaire Short Form (IPAQ)

    Time frame: twelve months

    level of physical activity

  26. Hand Dynamometer

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    hand grip strength

  27. Hand Dynamometer

    Time frame: twelve months

    hand grip strength

  28. 1 Minute Sit to Stand Test (1STS)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    physical capacity expressed with the number of repetitions

  29. 1 Minute Sit to Stand Test (1STS)

    Time frame: twelve months

    physical capacity expressed with the number of repetitions

  30. Timed Up and Go (TUG)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    physical capacity expressed with the duration in seconds

  31. Timed Up and Go (TUG)

    Time frame: twelve months

    physical capacity expressed with the duration in seconds

  32. Six Minute Walk Test

    Time frame: twelve months

    physical capacity expressed with the walking distance in meters

  33. Goal Attainment Scale (GAS)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    level of attainment of individual goal: +2 = much more than expected, +1 = somewhat more than expected, 0 = goal achieved than expected, -1 = somewhat less than expected, -2 = much less than expected

  34. Readiness for Hospital Discharge Scale (RHDS)

    Time frame: day of discharge (approx. 5 - 10 days after operation)

    readiness for hospital discharge; 9 items, min 0, max 36, higher scores indicating higher readniss to discharge

  35. 5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L)

    Time frame: three months

    health-related quality of life; 6 items, interpretation following an algorythm between 1 (best possible health condition) and <0 (worst possible health condition)

  36. 5-level EQ-5D Health-related Quality of Life Questionnaire (EQ-5D-5L)

    Time frame: twelve months

    health-related quality of life; 6 items, interpretation following an algorythm between 1 (best possible health condition) and <0 (worst possible health condition)

  37. Questionnaire for Health-Related Resource Use in an Elderly Population (FIMA)

    Time frame: twelve months

    use of health care services; 11 items collecting numbers of health care services and days of usage, min 0, higher scores indicating higher usage of services

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • BARMER
  • University Hospital Augsburg

Registry information

Official study title

Interdisciplinary and Cross-sectoral Perioperative Care Model in the Cardiac Surgery: Implementation in the Setting of Minimally-invasive Heart Valve Surgery (INCREASE)

Acronym: INCREASE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2021
Registry last updated
Dec 12, 2024

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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