The Bern Rehab Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years and older with a chronic non-communicable disease
Signed general informed consent
Referral to a comprehensive disease-specific rehabilitation program
Disqualifiers
Refuted or missing general informed consent for further use of health-related data and samples.
Trial population
Patients with chronic, non-communicable diseases participating in a comprehensive disease-specific rehabilitation program.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Comprehensive disease-specific rehabilitation
Other interventionParticipation 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.
Treatment groups
30,000 Participants
are divided into 4 treatment groupsGroup A: Patients with cancer1 intervention
Group B: Patients with cardiovascular diseases1 intervention
Group C: Patients with musculoskeletal diseases1 intervention
Group D: Patients with pulmonary diseases1 intervention
Trial outcomes
Primary outcomes
1
Short-term change (absolute and percentage) in cardiorespiratory fitness, measured as peak oxygen uptake (ml/min/kg) or 6 minute walking test (m)
Stratified by type of delivery and cohort
Time frame
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)2
Long-term change (absolute and percentage) in cardiorespiratory fitness, measured as peak oxygen uptake (ml/min/kg) or 6 minute walking test (m)
Stratified by type of delivery and cohort
Time frame
From discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) to one year follow-upSecondary outcomes
1
Short- and long-term change (absolute and percentage) in muscle strength, measured by grip strength (kg)
Stratified by type of delivery and cohort
Time frame
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up2
Short- and long-term change (absolute and percentage) in muscle mass index, measured by body impedance analysis (kg/height2)
Stratified by type of delivery and cohort
Time frame
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-up3
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
In patients participating in inpatient rehabilitation, stratified by cohort
Time frame
From rehabilitation entry to discharge (3 weeks) and from discharge to one year follow-up4
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)
Stratified by type of delivery and cohort
Time frame
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes) and from discharge to one year follow-upOther outcomes
1
Time trends of proportion of patient participating in digitally-enhanced or digital/telerehabilitation (percentage)
Stratified by type cohort
Time frame
12 months2
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)
Stratified by type of delivery and cohort
Time frame
From rehabilitation entry to discharge (3 weeks for inpatient, 12 weeks for outpatient programmes)Sponsors and contacts
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Source ClinicalTrials.gov