Heart Failure With Reduced Ejection FractionNCT07275931
Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study
A study testing Tailored implementation support in people with Heart Failure With Reduced Ejection Fraction, run by Linkoeping University at 1 site in Sweden.
Trial summary
The overall aim of this project is to evaluate the effects of a digital support program for patients with heart failure through a cluster-randomized controlled trial, and to investigate the outcomes of different implementation strategies using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Tailored implementation support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSweden
- Study dates
- 15 Dec 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with heart failure with reduced ejection fraction (HFrEF) or heart failure with midrange reduced ejection fraction (HFmrEF) (ejection fraction ≤50%) verified by echocardiography or Magnetic Resonance Imaging
- Access to BankID, a computer, tablet, or smartphone
- Aged ≥18 years
- Able to understand and communicate in Swedish
- Provided informed consent
Who cannot join
- Barriers to participation (e.g., not Swedish-speaking, cognitive impairment, severe mental illness, substance abuse)
- Life expectancy of less than six months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Linköping University Hospital
Linköping, Östergötland County, 581 85
Anna Strömberg, PhD, +46736569265, anna.stromberg@liu.se
About this study
Official title: Digital Support Program Via 1177 for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study for Evaluation of Effects and Implementation
The overall aim of this project is to evaluate the effects of a digital support program for patients with heart failure through a cluster-randomized controlled trial, and to investigate the outcomes of different implementation strategies using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), PRISM (Practical, Robust Implementation and Sustainability Model) and ERIC (Expert Recommendations for Implementing Change) framework.
Our primary hypothesis is that the digital support program will improve patients' perceived control over their heart failure, measured with the validated Control Attitude Scale.
Read more
Secondary hypotheses are that the program will increase patients' health-related quality of life, self-care behaviors, heart failure knowledge, perceived continuity of care, and participation in care, and reduce symptoms of depression.
Implementation aim (based on the RE-AIM, PRISM and ERIC frameworks) The implementation component of the study aims to compare two different implementation strategies: a standard (basic) support package versus a tailored, context-specific support strategy.
Heart failure clinics at hospitals an within primary care will be matched and randomized into two arms. The intervention arm will receive tailored implementation support to implement the support program. The control arm will recive implementation support according to a predefined standard procedure.
Researchers will compare the intervention arm with control arm to see if there are any differences regarding the implementationsuccess between the arms.
The patients in both arms will have access to the support program during six months.
Read the detailed description
Will be added
- Being tested
- Tailored implementation support
- Keywords
- Co-design, E-health, support, implementation, RE-AIM, PRISM, ERIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored implementation supportOther
Tailored implementation support
| Study group | Role | What they receive |
|---|---|---|
| Tailored implementation | Experimental | This arm will receive tailored implementation support. Receives: Other: Tailored implementation support |
| Control | No intervention | This group will receive standard implementation of the support program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived control attitudes
Measured with The Control Attitudes Scale-Revised. The scale has 8 item. The possible range for the total score is from 8 to 40. Higher scores reflect greater levels of perceived control.
Measured: At enrollment and at the end of the intervention at 6 month
Secondary outcomes (9)
Self-care
Measured using the European Heart Failure Self-care Behaviour Scale. The scale has 9 item. The possible range for the total score is from 0 to 100. Higher scores reflect greater levels of self-care.
Measured: At enrollment and at the end of the intervention at 6 month
Perceived control
Perceived Attitude Scale with 4 items. The possible range for the total score is from 4 to 28. Higher scores reflect higher levels of perceived control.
Measured: At enrollment and at the end of the intervention at 6 month
Heart failure knowledge
Heart failure knowledge scale has 3 parts. The first part has 15 knowledge questions and the possible range for the total is 0-15. Higher scores reflect greater levels of knowledge. The second part measures the trust the person with heart failure has in his/her knowledge with 3 items on a scale from 1-5 and the possible range for the total is 3-15. Higher scores reflect greater levels of trust.The third part measures perception of knowledge with 3 items on a scale from 1-5 and the possible range for the total is 3-15. Higher scores reflect greater levels of perceived knowledge.
Measured: At enrollment and at the end of the intervention at 6 month
Healthcare consumtion
Patient records of all health care consumption
Measured: From enrollment to 12 month follow-up
Health related quality of life
Measured with Euro-Qol EQ-5D, The scale has 6 item. The first 5 items comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state.
Item 6 is a Visual Analog Scale. The possible range for the total score is from 0 to 100. Higher scores reflect greater levels of health.
Measured: At enrollment and at the end of the intervention at 6 month
Disease specific health-related quality of life
Measured with Kansas City Cardiomyopathy questionnaire. The scale has 12 items assessing 4 domains (physical limitation, symptom frequency, quality of life, and social limitation), which can be reported separately into the subscales or summed into an overall score. The scales range from 0 to 100, with higher scores indicating a better health status and low symptom burden.
Measured: At enrollment and at the end of the intervention at 6 month
Symptoms of Depression
Measured with Patient Health Questionnare 9. The questionnaire has 9 items. The possible range for the total score is from 0 to 27. Higher score indicate more severe symptoms of depression.
Measured: At enrollment and at the end of the intervention at 6 month
Continuity of care
Measured with Patient experiences continuity of care with 20 items on continuity of care in 4 dimensions: information, relations, management and knowlegde. The possible range for the total score is from 20 to 80. Higher score indicate better continuity.
Measured: At enrollment and at the end of the intervention at 6 month
Electronic Health Literacy
Measured with Electronic health literacy scale. This scale contains 8 items and covers 3 dimensions: the ability to acquire, evaluate, and apply health information online. The scale uses a 5-point Likert scale, with responses ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The total score ranges from 8 to 40, with higher scores indicating higher levels of electronic health literacy.
Measured: At enrollment and at the end of the intervention at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start15 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anna Stroemberg, Linkoeping University
- Investigators
- Anna Stroemberg, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275931
- Sponsor's protocol ID
- 2023-04289-01
- Other IDs
- 2023
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Support Program Via 1177 for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study for Evaluation of Effects and Implementation
- ClinicalTrials.gov ID
- NCT07275931
- Acronym / sponsor ID
- 2023-04289-01
- Keywords
- Co-design, E-health, support, implementation, RE-AIM, PRISM, ERIC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 10 Dec 2025 (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 overall aim of this project is to evaluate the effects of a digital support program for patients with heart failure through a cluster-randomized controlled trial, and to investigate the outcomes of different implementation strategies using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), PRISM (Practical, Robust Implementation and Sustainability Model) and ERIC (Expert Recommendations for Implementing Change) framework.
Our primary hypothesis is that the digital support program will improve patients' perceived control over their heart failure, measured with the validated Control Attitude Scale.
Secondary hypotheses are that the program will increase patients' health-related quality of life, self-care behaviors, heart failure knowledge, perceived continuity of care, and participation in care, and reduce symptoms of depression.
Implementation aim (based on the RE-AIM, PRISM and ERIC frameworks) The implementation component of the study aims to compare two different implementation strategies: a standard (basic) support package versus a tailored, context-specific support strategy.
Heart failure clinics at hospitals an within primary care will be matched and randomized into two arms. The intervention arm will receive tailored implementation support to implement the support program. The control arm will recive implementation support according to a predefined standard procedure.
Researchers will compare the intervention arm with control arm to see if there are any differences regarding the implementationsuccess between the arms.
The patients in both arms will have access to the support program during six months.
Detailed description
Will be added
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored implementation | Experimental | Other: Tailored implementation supportThis arm will receive tailored implementation support. |
| Control | No intervention | –This group will receive standard implementation of the support program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with heart failure with reduced ejection fraction (HFrEF) or heart failure with midrange reduced ejection fraction (HFmrEF) (ejection fraction ≤50%) verified by echocardiography or Magnetic Resonance Imaging
- Access to BankID, a computer, tablet, or smartphone
- Aged ≥18 years
- Able to understand and communicate in Swedish
- Provided informed consent
Key exclusion criteria (2 listed)
- Barriers to participation (e.g., not Swedish-speaking, cognitive impairment, severe mental illness, substance abuse)
- Life expectancy of less than six months
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 |
|---|---|---|
| Tailored implementation supportTailored implementation support | Other | Tailored implementation |
Primary outcome
Perceived control attitudes
Time frame: At enrollment and at the end of the intervention at 6 month
Measured with The Control Attitudes Scale-Revised. The scale has 8 item. The possible range for the total score is from 8 to 40. Higher scores reflect greater levels of perceived control.
9 secondary outcomes
Self-care
Time frame: At enrollment and at the end of the intervention at 6 month
Perceived control
Time frame: At enrollment and at the end of the intervention at 6 month
Heart failure knowledge
Time frame: At enrollment and at the end of the intervention at 6 month
Healthcare consumtion
Time frame: From enrollment to 12 month follow-up
Health related quality of life
Time frame: At enrollment and at the end of the intervention at 6 month
Disease specific health-related quality of life
Time frame: At enrollment and at the end of the intervention at 6 month
Symptoms of Depression
Time frame: At enrollment and at the end of the intervention at 6 month
Continuity of care
Time frame: At enrollment and at the end of the intervention at 6 month
Electronic Health Literacy
Time frame: At enrollment and at the end of the intervention at 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Link to the support programLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Heart Failure
Recruiting
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
Heart Failure With Reduced Ejection Fraction
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07328948 in Adults With Heart Failure (BRANCH-HF)
Heart Failure
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction
RecruitingPhase 1/2
Endocardial Delivery for Myocardial Regeneration Using Allogeneic iPSC-derived Cardiomyocyte Spheroids for HF With Systolic Dysfunction (EMERALD Study)
Heart Failure, Ischemic Heart Failure
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.
Anna Stroemberg principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored implementation support in people with Heart Failure With Reduced Ejection Fraction, run by Linkoeping University at 1 site in Sweden.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Stroemberg, Professor (+46736569265, anna.stromberg@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived control attitudes (time frame: At enrollment and at the end of the intervention at 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2026.