Heart Failure Clinical Trial
— SMART-HFOfficial title:
Selfcare Management Intervention in Heart Failure
Verified date | April 2021 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A novel tool for self-care enhancement for heart failure (HF) patients has been developed. In this randomized controlled trial, patients will be randomized 1:1 to either receive the home-based tool (OPTILOGG) or standard care. The intervention will go on for 8 months, and outcomes are self-care, cardiovascular events (including emergency visits, admissions, number of in-hospital days).
Status | Completed |
Enrollment | 124 |
Est. completion date | December 13, 2019 |
Est. primary completion date | October 18, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Diagnosed heart failure, International classification of diseases (ICD): I50, existing or de-novo, in NYHA-class II-IV - Admission for HF within the last 12 months - Filled out consent form - Expected to be able to use the tool, if allocated to the intervention group Exclusion Criteria: - Decline to participate - More than mild cognitive impairment - Expectancy of life < 8 months - For other reasons deemed inappropriate to be enrolled, e.g. participating in another study affecting standard care |
Country | Name | City | State |
---|---|---|---|
Sweden | Region Skåne | Lund | Skåne |
Lead Sponsor | Collaborator |
---|---|
Lund University | Region Skane |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of HF admissions | All admissions will be adjudicated as HF-related or non-HF related, and the frequency of hospital admissions for HF will be analyzed on the group level. | Eight months | |
Other | Number of ER-visits | It is possible that patients get admitted through other pathways than through the ER. To analyze this we will analyze HF-related ER-visits and contrast with HF-admissions to explore potential differences in care pathways between the two groups. | Eight months | |
Other | Adherence to the intervention | Each system will register all patient interactions. The adherence for each patient expressed as a frequency will be analyzed. This only pertains to the IG. | Eight months. | |
Primary | Self-care behaviour | Registered using the European Heart Failure Self-care Behaviour Scale (EHFScB), a validated instrument for measuring heart failure (HF) self-care behaviour. The questionnaire is made up of 9 items, where the respondent can choose between 5 different answers to each of the 9 statements. Each item thus generates a score between 1 and 5. The total score for the instrument is between 9 and 45, with 9 constituting the best, or most desireable self-care behaviour and 45 the worst. Data will be analyzed on a group level using Mann-Whitney-U test for independent samples. |
Eight months | |
Secondary | Number of HF related days in the hospital | All in-hospital days will be adjudicated as HF-related, or non-HF related. The HF-related in-hospital days will then be analyzed on the group level. | Eight months | |
Secondary | Event-free survival | Composite endpoint of HF-admissions, HF related ER visits, all-cause mortality | Eight months |
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