Clinical trial NCT03484286: Selfcare Management Intervention in Heart Failure
Official title: Selfcare Management Intervention in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Region Skane
First posted: 2018-03-30
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallell randomized clinical trial with continuous sampling and a 1:1 randomization.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: Patients will be recruited using continuous sampling, and will be approached either in connection with being discharged after a heart failure (HF) related event or upon visiting an out-patient HF clinic if the patient has been admitted for HF at least once the last year.

After written consent has been given, demographical data will be noted, and the patient will complete forms: the European Heart Failure Self-care Behaviour scale 9-item questionnaire (EHFScB-9) and self-assessment of symtoms (NYHAclass). Expected time for this is 20 minutes. The baseline demographical data will include age, gender, ejection-fraction, New York Heart Association (NYHA)-class, blood pressure, heart rate, HF aetiology, and other routine tests for HF visits as outlined in the European guidelines for HF treatment.

After the patient has filled out the forms, the patient will be randomized to the control group (CG) meaning standard care, or the intervention group (IG). Patients allocated to the IG will be equipped with the home based self-care enhancement tool OPTILOGG. OPTILOGG assists the patient with symptom monitoring and flexible diuretics regimen, as well as education about living with HF. It consists of a specialized tablet computer wirelessly connected to a weight scale. OPTILOGG is CE-marked. The intervention will be deployed for eight months. After the eight months, the patients will be called to a follow-up visit. During the visit all data that was collected at baseline/recruitment will be collected again. All cardiovascular events for each patient will be retrieved, for the eight months during which the intervention was deployed, but also for the following 12 months. These events include hospital admissions, ER-visits and number of in-hospital days.

Based off of previous findings in the literature, target for enrollment was set at 70 + 70 patients, to achieve statistical significance with 80% power.

Eligibility criteria: 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

Primary outcomes:
measure: Self-care behaviour
timeFrame: Eight months
Secondary outcomes:
measure: Number of HF related days in the hospital
timeFrame: Eight months
measure: Event-free survival
timeFrame: Eight months
Other outcomes:
measure: Number of HF admissions
timeFrame: Eight months
measure: Number of ER-visits
timeFrame: Eight months
measure: Adherence to the intervention
timeFrame: Eight months.
Locations:
city: Lund
country: Sweden
facility: Region Skåne
state: Skåne
Study officials:
affiliation: Lund University
name: Sofia Gerward, PhD
role: PRINCIPAL_INVESTIGATOR
References: