Heart Failure NYHA Class INCT03388918
Future Patient - Telerehabilitation of Heart Failure Patients
A study testing Telerehabilitation in people with Heart Failure NYHA Class I and Heart Failure NYHA Class II, run by Aalborg University at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class I, Heart Failure NYHA Class II, Heart Failure NYHA Class III
- What is being tested?
- Telerehabilitation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Dec 2016to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with HF according to New York Heart Association (NYHA) Class I-IV with max 20 % in class I or who have a current hospitalization for acute decompensated HF within the past two weeks
- Adults (18 years or older); no upper age limit
- Patients living in Viborg and Skive Municipality
- Living at home and capable of caring for him/herself
- Have basic computer skills or a relative who have basic computer skills
- Informed consent to participate in a telerehabilitation program
- May have a pacemaker
Who cannot join
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, musculoskeletal or cognitive disability or active psychiatric history (as noted in the medical record) other than depression or anxiety related to cardiac or other chronic illness
- Lack of ability to cooperate
- Does not speak Danish
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- To increase the quality of life for patients with Heart Failure (HF)
- To optimize the medical treatment of patients with HF
- To perform multi-parametric (subjective and objective) individualized monitoring in order to detect worsening of symptoms and avoid hospitalizations
- To increase physical activities for patients with heart failure in everyday life in a telerehabilitation program
- To facilitate patient-initiated self-care management actions upon the following early detection of changes in source data (steps taken, weight, blood pressure, pulse, sleep, illness perception, motivation, anxiety and depression)
- To evaluate patients health literacy and e-health literacy participating in a telerehabilitation program and rehabilitation program
- To test and evaluate the Heart Portal - a digital toolbox for improved self-management for patients with heart failure and their relatives
- To explore the experiences and perspectives of the patients and their relatives when being part of a telerehabilitation program
- To test and evaluate a cross sector communication platform from a patient and healthcare professional perspective
- To perform a cost-effectiveness analysis of total costs of healthcare and rehabilitation services
- Conditions
- Heart Failure NYHA Class I, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV, Acute Decompensated Heart Failure
- Being tested
- Telerehabilitation
- Keywords
- Quality of life, Telerehabilitation, Cardiac patients, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Telerehabilitation |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Secondary outcomes (14)
Time from baseline to optimized medical treatment
Time for optimizing medicine
Measured: 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
All-cause hospitalization at end of rehabilitation
Measured: For both intervention and control group: 6 months
Steps taken
Numbers of steps taken in the intervention group
Measured: Intervention group: Everyday for 12 months
Development of bloodpressure
Intervention group: Blood pressure (mmHG)
Measured: 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)
Measured: Intervention group: Pulse from date of randomization and every day in 12 months
Development of weight
Intervention group: Weight (Kilograms)
Measured: Intervention group: Weight from date of randomization and every day in 12 months
Sleep
Intervention group: Sleep ( numbers of hours per night)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: For both intervention and control group: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start21 Dec 2016
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure NYHA Class IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aage og Johanne Louis-Hansens Fond, Viewcare A/S, Laboratory of Welfare Technologies - Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University, Regionshospitalet Viborg, Skive, Technical University of Denmark, University of Aarhus, Danish Heart Foundation, Viborg Healthcare Center, Skive Healthcare Center, Odense University Hospital, Department of Computer Science, AAU
- Responsible party
- Principal investigator, Birthe Dinesen, Aalborg University
- Investigators
- Birthe Dinesen, PhD, Principal investigator, Aalborg UniversityMalene Hollingdal, MD, PhD, Study director, Central Jutland Regional HospitalJens Refsgaard, MD, PhD, Study director, Central Jutland Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388918
- Sponsor's protocol ID
- N-20160055
- Status last verified
- May 2021
- First submitted
- 24 Aug 2017
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for sharing protocol as we are applying for patent.
Publications
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.
PubMed 35928510Skov 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.
PubMed 34255642Dinesen 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.
PubMed 31538944
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Patient - Telerehabilitation of Heart Failure Patients
- ClinicalTrials.gov ID
- NCT03388918
- Acronym / sponsor ID
- N-20160055
- Conditions
- Heart Failure NYHA Class I, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV, Acute Decompensated Heart Failure
- Keywords
- Quality of life, Telerehabilitation, Cardiac patients, Heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aage og Johanne Louis-Hansens Fond, Viewcare A/S, Laboratory of Welfare Technologies - Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University, Regionshospitalet Viborg, Skive, Technical University of Denmark, University of Aarhus, Danish Heart Foundation, Viborg Healthcare Center, Skive Healthcare Center, Odense University Hospital, Department of Computer Science, AAU
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To increase the quality of life for patients with Heart Failure (HF)
- To optimize the medical treatment of patients with HF
- To perform multi-parametric (subjective and objective) individualized monitoring in order to detect worsening of symptoms and avoid hospitalizations
- To increase physical activities for patients with heart failure in everyday life in a telerehabilitation program
- To facilitate patient-initiated self-care management actions upon the following early detection of changes in source data (steps taken, weight, blood pressure, pulse, sleep, illness perception, motivation, anxiety and depression)
- To evaluate patients health literacy and e-health literacy participating in a telerehabilitation program and rehabilitation program
- To test and evaluate the Heart Portal - a digital toolbox for improved self-management for patients with heart failure and their relatives
- To explore the experiences and perspectives of the patients and their relatives when being part of a telerehabilitation program
- To test and evaluate a cross sector communication platform from a patient and healthcare professional perspective
- To perform a cost-effectiveness analysis of total costs of healthcare and rehabilitation services
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: TelerehabilitationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with HF according to New York Heart Association (NYHA) Class I-IV with max 20 % in class I or who have a current hospitalization for acute decompensated HF within the past two weeks
- Adults (18 years or older); no upper age limit
- Patients living in Viborg and Skive Municipality
- Living at home and capable of caring for him/herself
- Have basic computer skills or a relative who have basic computer skills
Key exclusion criteria (5 listed)
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, musculoskeletal or cognitive disability or active psychiatric history (as noted in the medical record) other than depression or anxiety related to cardiac or other chronic illness
- Lack of ability to cooperate
- Does not speak Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationBlood 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) | Device | Intervention group |
Primary outcome
Increased quality of life
Time frame: 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
Increased quality of life as measured by a moderate change (10 points) in quality of life measured by Kansas City Questionnaire (KCCQ)
14 secondary outcomes
Time from baseline to optimized medical treatment
Time frame: 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
Time frame: For both intervention and control group: 6 months
Steps taken
Time frame: Intervention group: Everyday for 12 months
Development of bloodpressure
Time frame: Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months
Development of pulse
Time frame: Intervention group: Pulse from date of randomization and every day in 12 months
Development of weight
Time frame: Intervention group: Weight from date of randomization and every day in 12 months
Sleep
Time frame: Intervention group: Sleep from date of randomization and accessed up to 12 months
Illness perception
Time frame: For Intervention and control group: At baseline, 6 & 12 months
Motivation
Time frame: For both intervention and control group: At baseline, 6 & 12 months
Anxiety and depression
Time frame: For both intervention and control group: At baseline, 6 & 12 months
Health- literacy
Time frame: For both intervention and control group: At baseline
eHealth literacy
Time frame: For both intervention and control group: At baseline, 6 & 12 months
Experiences of using the Heart portal
Time frame: For intervention group: 6 & 12 months
Costs of healthcare and rehabilitation services
Time frame: For both intervention and control group: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 35928510Spindler 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.
- Derived from this study: PubMed 34255642Skov 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.
- Derived from this study: PubMed 31538944Dinesen 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.
- Individual participant dataSharing planned: No. No plan for sharing protocol as we are applying for patent.
Related trials for Heart Failure NYHA Class I
Not yet recruitingPhase 1/2
HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
Advanced Heart Failure, Ischemic Heart Failure
Recruiting
Promoting Well-being and Health in Heart Failure
Heart Failure, Heart Failure NYHA Class I
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birthe Dinesen, PhD principal investigator
Aalborg University
Malene Hollingdal, MD, PhD study director
Central Jutland Regional Hospital
Jens Refsgaard, MD, PhD study director
Central Jutland Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Heart Failure NYHA Class I and Heart Failure NYHA Class II, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased quality of life (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388918, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.