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NCT Number: NCT07275931

Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University Hospital

Linköping, Östergötland County, 581 85, Sweden

Location status: Recruiting

Location contact

Anna Strömberg, PhD

CONTACT

[email protected]

+46736569265

About this study

Will be added

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Barriers to participation (e.g., not Swedish-speaking, cognitive impairment, severe mental illness, substance abuse)
  • Life expectancy of less than six months

Treatment and study plan

Tailored implementation support

Other

Tailored implementation support

Primary outcomes

  1. 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.

Secondary outcomes

  1. Self-care

    Time frame: At enrollment and at the end of the intervention at 6 month

    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.

  2. Perceived control

    Time frame: At enrollment and at the end of the intervention at 6 month

    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.

  3. Heart failure knowledge

    Time frame: At enrollment and at the end of the intervention at 6 month

    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.

  4. Healthcare consumtion

    Time frame: From enrollment to 12 month follow-up

    Patient records of all health care consumption

  5. Health related quality of life

    Time frame: At enrollment and at the end of the intervention at 6 month

    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.

  6. Disease specific health-related quality of life

    Time frame: At enrollment and at the end of the intervention at 6 month

    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.

  7. Symptoms of Depression

    Time frame: At enrollment and at the end of the intervention at 6 month

    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.

  8. Continuity of care

    Time frame: At enrollment and at the end of the intervention at 6 month

    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.

  9. Electronic Health Literacy

    Time frame: At enrollment and at the end of the intervention at 6 month

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Stroemberg, Professor

CONTACT

[email protected]

+46736569265

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

Digital Support Program Via 1177 for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study for Evaluation of Effects and Implementation

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 10, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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