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

NCT07275931 | Recruiting

• 1 other identifier: 2023-04289-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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), 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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Co-design; E-health; support; implementation; RE-AIM; PRISM; ERIC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Self-care

  At enrollment and at the end of the intervention at 6 month

• Perceived control

  At enrollment and at the end of the intervention at 6 month

• Heart failure knowledge

  At enrollment and at the end of the intervention at 6 month

• Healthcare consumtion

  From enrollment to 12 month follow-up

• Health related quality of life

  At enrollment and at the end of the intervention at 6 month

Study Arms (2)

Tailored implementation

EXPERIMENTAL

This arm will receive tailored implementation support.

Other: Tailored implementation support

Control

NO INTERVENTION

This group will receive standard implementation of the support program.

Interventions

Tailored implementation support OTHER

Tailored implementation support

Tailored implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping University Hospital

Linköping, Östergötland County, 581 85, Sweden

RECRUITING

Related Links

• Link to the support program

Study Officials

• Anna Stroemberg

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Stroemberg, Professor

CONTACT

+46736569265; anna.stromberg@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 10, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)