Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study
NCT ID: NCT07275931
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
240 participants
INTERVENTIONAL
2025-12-01
2029-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Tailored implementation
This arm will receive tailored implementation support.
Tailored implementation support
Tailored implementation support
Control
This group will receive standard implementation of the support program.
No interventions assigned to this group
Interventions
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Tailored implementation support
Tailored implementation support
Eligibility Criteria
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Inclusion Criteria
* Access to BankID, a computer, tablet, or smartphone
* Aged ≥18 years
* Able to understand and communicate in Swedish
* Provided informed consent
Exclusion Criteria
* Life expectancy of less than six months
18 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Anna Stroemberg
Professor
Principal Investigators
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Anna Stroemberg
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Linköping University Hospital
Linköping, Östergötland County, Sweden
Countries
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Central Contacts
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Related Links
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Link to the support program
Other Identifiers
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2023-04289-01
Identifier Type: -
Identifier Source: org_study_id
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