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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: Tailored implementation support

Detailed Description

Will be added

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Stroemberg, Professor; Phone Number: +46736569265; Email: anna.stromberg@liu.se

Study Locations

• Sweden
  • Östergötland County
    • Linköping, Östergötland County, Sweden, 581 85
      • Recruiting
      • Linkoping University Hospital
      • Contact: Anna Strömberg, PhD; Phone Number: +46736569265; Email: anna.stromberg@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored implementation; This arm will receive tailored implementation support.	Other: Tailored implementation support; Tailored implementation support
No Intervention: Control; This group will receive standard implementation of the support program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At enrollment and at the end of the intervention at 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At enrollment and at the end of the intervention at 6 month
Healthcare consumtion	Patient records of all health care consumption	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.	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.	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.	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.	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.	At enrollment and at the end of the intervention at 6 month

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Principal Investigator: Anna Stroemberg, Linkoeping University

Publications and helpful links

Helpful Links

• Link to the support program

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: implementation; E-health; support; PRISM; Co-design; RE-AIM; ERIC
• Other Study ID Numbers: 2023-04289-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No