Selfcare Management Intervention in Heart Failure (SMART-HF)

Lund University

Status: Completed

Conditions: Heart Failure

Treatments: Other: Standard care; Device: OPTILOGG

Study type: Interventional

Funder types: Other

Identifiers

NCT03484286

SMART-HF

Details and patient eligibility

About

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).

Full 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.

Enrollment: 124 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

124 participants in 2 patient groups

Control group

Other group

Description:

Subject to standard care. No interventions above and beyond what is deemed standard care for heart failure patients in the region where the study takes place.

Treatment:

Other: Standard care

Intervention group

Experimental group

Description:

Device: OPTILOGG

Treatment:

Device: OPTILOGG