The Bern Rehab Registry (BernRehabReg)

August 15, 2024 updated by: Insel Gruppe AG, University Hospital Bern

The Bern Rehab Registry - a Prospective Cohort Study in Patients With Chronic Non-communicable Diseases Participating in a Comprehensive Rehabilitation Programme

This study examines the health outcomes of patients with long-term illnesses such as cancer, heart, lung, or musculoskeletal diseases who participate in a rehabilitation programme. The programme may involve staying in a facility (inpatient), visiting a facility (outpatient), home-based care supported by digital health tools (telerehabilitation), or a combination of facility- and home-based options.

The key health outcomes being measured include physical fitness and strength, body composition (like body fat and muscle mass), specific risk factors related to the diseases, and patients' self-reported health and experience outcomes, such as feelings of anxiety, depression, fatigue, overall quality of life, and satisfaction with the rehabilitation programme.

These measurements provide important information about the patients' lung, heart, and muscle health, as well as their mental well-being. They also help to predict the likelihood of further health complications, the chance of needing to be hospitalized again, and overall quality of life. This information is useful for improving the quality of care, tailoring future provision of rehabilitation services and long-term care for patients with chronic conditions.

Additionally, the study will provide insights into how new technologies like telerehabilitation are implemented, including how well they are adopted, followed, and accepted by patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

The global demographic landscape is shifting towards an aging population, coupled with a rise in chronic, non-communicable diseases that contribute to disability and escalating healthcare costs. Recognizing this, the World Health Organization (WHO) has identified rehabilitation as a key strategy for health in the 21st century.

Aim:

The aim of this prospective cohort study is to assess the outcomes of disease-specific comprehensive rehabilitation programmes at a tertiary referral center to improve the quality of care and formulate novel research questions.

Methods:

Consecutive patients with cancer, cardiovascular, musculoskeletal, or pulmonary diseases, referred for comprehensive rehabilitation to the Centre for Rehabilitation & Sports Medicine (two locations - Berner Reha Centre and Inselspital) of the Insel Group, Bern, Switzerland, will be included. Patients will be counselled by trained advanced practice nurses, and type of delivery of the rehabilitation programme will be based on medical needs and patient preferences. Three-week inpatient programmes are performed at the Berner Reha Centre and Inselspital. Twelve-week outpatient programmes are performed at the Inselspital and delivered as centre-based, digitally-enhanced centre- and home-based, or home-based digital/tele rehabilitation.

Outcome assessments will be based on the framework of the International Classification of Functioning, Disability, and Health (ICF) of the World Health Organisation.

Study Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Reha Inselspital, Bern University Hospital, Centre for Rehabilitation & Sports Medicine, Insel Group
        • Contact:
    • Bern
      • Heiligenschwendi, Bern, Switzerland, 3625
        • Recruiting
        • Berner Reha Centre, Centre for Rehabilitation & Sports Medicine, Insel Group
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic, non-communicable diseases participating in a comprehensive disease-specific rehabilitation program.

Description

Inclusion Criteria:

  • Patients aged 18 years and older with a chronic non-communicable disease
  • Signed general informed consent
  • Referral to a comprehensive disease-specific rehabilitation program

Exclusion Criteria:

  • Refuted or missing general informed consent for further use of health-related data and samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with cancer
Age 18+ years, indication for cancer rehabilitation
Other: Comprehensive disease-specific rehabilitation

Participation in (a) inpatient rehabilitation, (b) outpatient centre-based, (c) outpatient digitally-enhanced centre- and home-based, or (d) outpatient home-based digital/tele rehabilitation.

Duration is 3 weeks for inpatient and 12 weeks for outpatient programmes.
Patients with cardiovascular diseases
Age 18+ years, indication for cardiovascular rehabilitation
Other: Comprehensive disease-specific rehabilitation

Participation in (a) inpatient rehabilitation, (b) outpatient centre-based, (c) outpatient digitally-enhanced centre- and home-based, or (d) outpatient home-based digital/tele rehabilitation.

Duration is 3 weeks for inpatient and 12 weeks for outpatient programmes.
Patients with musculoskeletal diseases
Age 18+ years, indication for musculoskeletal rehabilitation
Other: Comprehensive disease-specific rehabilitation

Participation in (a) inpatient rehabilitation, (b) outpatient centre-based, (c) outpatient digitally-enhanced centre- and home-based, or (d) outpatient home-based digital/tele rehabilitation.

Duration is 3 weeks for inpatient and 12 weeks for outpatient programmes.
Patients with pulmonary diseases
Age 18+ years, indication for pulmonary rehabilitation
Other: Comprehensive disease-specific rehabilitation

Participation in (a) inpatient rehabilitation, (b) outpatient centre-based, (c) outpatient digitally-enhanced centre- and home-based, or (d) outpatient home-based digital/tele rehabilitation.

Duration is 3 weeks for inpatient and 12 weeks for outpatient programmes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term change (absolute and percentage) in cardiorespiratory fitness, measured as peak oxygen uptake (ml/min/kg) or 6 minute walking test (m)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)
Long-term change (absolute and percentage) in cardiorespiratory fitness, measured as peak oxygen uptake (ml/min/kg) or 6 minute walking test (m)
Time Frame: From discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) to one year follow-up
Stratified by type of delivery and cohort
From discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) to one year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short- and long-term change (absolute and percentage) in muscle strength, measured by grip strength (kg)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term change (absolute and percentage) in muscle mass index, measured by body impedance analysis (kg/height2)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in markers of anxiety, measured by Generalized Anxiety Disorder-7 questionnaire score (range from 0 to 21, higher values indicate more severe anxiety)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in markers of depression, measured by Patient Health Questionnaire-9 score (range from 0 to 27, higher values indicate more severe depression)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in office systolic blood pressure (mmHg)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in LDL-cholesterol (mmol/l)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in HbA1c (percentage)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Composite outcome, stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in hsCRP (mg/l)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in body mass index (kg/m2)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in body fat, assessed by body impedance analysis (%)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in steps per day, assessed by wrist-worn accelerometer (n)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in smoking status, assessed by questionnaire (current, former, non-smoker)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Composite outcome, stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in adherence to guideline-directed medical therapies (percentage of recommended medical substances taken)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Return to work (yes, no)
Time Frame: At rehabilitation discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and at one year follow-up
Stratified by type of delivery and cohort
At rehabilitation discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and at one year follow-up
Short- and long-term changes (absolute and percentage) in markers of health-related quality of life, measured by Kansas City Cardiomyopathy Questionnaire-23 score (range from 0 to 100, higher values indicate better QoL)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
In patients with heart failure, stratified by type of delivery
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in markers of health-related quality of life, measured by HearQoL questionnaire score (range from 0 to 3, higher values indicate better QoL)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
In patients with heart disease participating in outpatient cardiac rehabilitation or telerehabilitation
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in markers of health-related quality of life, measured by MacNew questionnaire score (range 0 to 7, higher values indicate better QoL)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
In patients with heart disease participating in inpatient cardiac rehabilitation
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in markers of health-related quality of life, measured by Chronic Respiratory Disease Questionnaire score (range 1 to 7, higher values indicate better QoL)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
In patients with pulmonary disease, stratified by type of delivery
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term changes (absolute and percentage) in markers of health-related quality of life, measured by Functional Assessment of Cancer Therapy-General questionnaire score (range 1 to 5, higher values indicate better QoL)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
In patients with cancer, stratified by type of delivery
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up
Short- and long-term change (absolute and percentage) in the Extended Barthel Index (EBI, range from 0 to 64) or the Functional Independence Measure (FIM, range from 0 to 126), higher values indicate better levels physical and/or mental functioning
Time Frame: From rehabilitation entry to discharge (3 weeks) and from discharge to one year follow-up
In patients participating in inpatient rehabilitation, stratified by cohort
From rehabilitation entry to discharge (3 weeks) and from discharge to one year follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time trends of proportion of patient participating in digitally-enhanced or digital/telerehabilitation (percentage)
Time Frame: 12 months
Stratified by type cohort
12 months
Assessment of patient reported experience measures (PREMS) by a self-designed questionnaire on satisfaction with the rehabilitation programme (range 1 to 10, higher values indicate higher satisfaction)
Time Frame: From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)
Stratified by type of delivery and cohort
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

  • Principal Investigator: Matthias Wilhelm, MD, Centre for Rehabilitation & Sports Medicine, Insel Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-00480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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