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| Name | Class |
|---|---|
| Aage og Johanne Louis-Hansens Fond | OTHER |
| Viewcare A/S | UNKNOWN |
| Laboratory of Welfare Technologies - Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University |
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The idea behind the Future Patient research project is to develop a telerehabilitation program and tools for patients with heart failure.
The hypothesis for this study is that participation in a telerehabilitation program for patients with heart failure will increase the patients' quality of life and multi-parametric (subjective and objective) individualized monitoring in a telerehabilitation program for patients with heart failure will increase detection of worsening of symptoms and avoid future hospitalization of the HF-patients.
The overall aim is to test, implement and evaluate a telerehabilitation program for patients with heart failure from clinical, psychosocial, health literacy and e-health literacy, inter-organizational, health economic and technical perspectives.
Furthermore, this study has sub aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group has three steps: Step I: Titration of medicine ( 0-3 months) Step II: Telerehabilitation program at healthcare center or by call center ( 3 months) Step III: Rehabilitation in everyday life ( 6 months) The patients is monitoring vital signs such as blood pressure, pulse, weight, steps, respiration, and sleep. Have access to a Heart Portal that is an information cite on heart failure. Via the portal patients can see measured values & communicate with staff. Every other week the patients fill in an online questionnaires on symptoms, sleep and well being. |
|
| Traditional rehabilitation group | No Intervention | This group follows the International Cardiac Guidelines. There are three steps in this arm: Step I: Titration of medicine (3 months). Step II: Traditional rehabilitation at the healthcare center ( 3 months). Step III: Everyday life with HF ( 6 months) The participants do not have access to the Heart Portal and is not monitoring any vital signs. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Device | Blood pressure (A&D Medical UA 767PBT), weight (A&D Medical UC-321PBT), step counters(Fitbit Zip & Charge), sleep sensor (Beddit 3), tablet (iPAD Air 2) & transmitter (Qualcomm Life, QWH-HUB-V1.0E) |
| Measure | Description | Time Frame |
|---|---|---|
| Increased quality of life | Increased quality of life as measured by a moderate change (10 points) in quality of life measured by Kansas City Questionnaire (KCCQ) | Intervention group: At baseline, week 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32, 34,36,38,40,42,44,46,48,50,52 Control group: Baseline, 6 & 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time from baseline to optimized medical treatment | Time for optimizing medicine | For both intervention and control group: From date of randomization until the date of first documented progression with medical treatment, assessed up to 4 months |
| All cause hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birthe Dinesen, PhD | Aalborg University | Principal Investigator |
| Malene Hollingdal, MD, PhD | Central Jutland Regional Hospital | Study Director |
| Jens Refsgaard, MD, PhD | Central Jutland Regional Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Ward, Viborg Hospital | Viborg | 8800 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35928510 | Derived | Spindler H, Dyrvig AK, Schacksen CS, Anthonimuthu D, Frost L, Gade JD, Kronborg SH, Mahboubi K, Refsgaard J, Dinesen B, Hollingdal M, Kayser L. Increased motivation for and use of digital services in heart failure patients participating in a telerehabilitation program: a randomized controlled trial. Mhealth. 2022 Jul 20;8:25. doi: 10.21037/mhealth-21-56. eCollection 2022. | |
| 34255642 |
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No plan for sharing protocol as we are applying for patent.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Regionshospitalet Viborg, Skive | OTHER |
| Technical University of Denmark | OTHER |
| University of Aarhus | OTHER |
| Danish Heart Foundation | OTHER |
| Viborg Healthcare Center | UNKNOWN |
| Skive Healthcare Center | UNKNOWN |
| Odense University Hospital | OTHER |
| Department of Computer Science, AAU | UNKNOWN |
Randomised controlled trial
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All-cause hospitalization at end of rehabilitation |
| For both intervention and control group: 6 months |
| Steps taken | Numbers of steps taken in the intervention group | Intervention group: Everyday for 12 months |
| Development of bloodpressure | Intervention group: Blood pressure (mmHG) | Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months |
| Development of pulse | Intervention group: Pulse ( numbers per minutes) | Intervention group: Pulse from date of randomization and every day in 12 months |
| Development of weight | Intervention group: Weight (Kilograms) | Intervention group: Weight from date of randomization and every day in 12 months |
| Sleep | Intervention group: Sleep ( numbers of hours per night) | Intervention group: Sleep from date of randomization and accessed up to 12 months |
| Illness perception | Positive changes in illness perceptions, from dysfunctional to functional measured by Illness perception questionaire | For Intervention and control group: At baseline, 6 & 12 months |
| Motivation | Changes from extrinsic to intrinsic motivation measured from baseline to end of rehabilitation and 6 months after end of rehabilitation measured by Health Climate Change Questionaire | For both intervention and control group: At baseline, 6 & 12 months |
| Anxiety and depression | Explore whether levels of anxiety and depression in the intervention group are lower or equivalent to the control group measured by Hospital Anxiety and Depression Scale (HADS) questionnaire | For both intervention and control group: At baseline, 6 & 12 months |
| Health- literacy | Health literacy in intervention and control group measured by Health Literacy Questionnaire (Danish validated version HLQ) by units on a scale | For both intervention and control group: At baseline |
| eHealth literacy | Improvement in e-health literacy in intervention and control group measured by eHealth Literacy Questionnaire (Danish validated version eHLQ) by units on a scale | For both intervention and control group: At baseline, 6 & 12 months |
| Experiences of using the Heart portal | Qualitative exploration of experiences of HF patients, relatives and healthcare professionals use of the Heart portal | For intervention group: 6 & 12 months |
| Costs of healthcare and rehabilitation services | Number of hospitalizations, number of contacts with heart failure clinic, days at hospital, contacts with general practitioners, number of participations in rehabilitation activities at healthcare center between intervention and control group | For both intervention and control group: 6 months |
| Derived |
| Skov Schacksen C, Dyrvig AK, Henneberg NC, Dam Gade J, Spindler H, Refsgaard J, Hollingdal M, Dittman L, Dremstrup K, Dinesen B. Patient-Reported Outcomes From Patients With Heart Failure Participating in the Future Patient Telerehabilitation Program: Data From the Intervention Arm of a Randomized Controlled Trial. JMIR Cardio. 2021 Jul 2;5(2):e26544. doi: 10.2196/26544. |
| 31538944 | Derived | Dinesen B, Dittmann L, Gade JD, Jorgensen CK, Hollingdal M, Leth S, Melholt C, Spindler H, Refsgaard J. "Future Patient" Telerehabilitation for Patients With Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Sep 19;8(9):e14517. doi: 10.2196/14517. |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |