Selfcare Management Intervention in Heart Failure

NCT ID: NCT03484286

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2019-12-13

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: OTHER

Standard care

Intervention Type: OTHER

Patients in the control group will be subject to standard heart failure care.

Intervention group

Device: OPTILOGG

Group Type: EXPERIMENTAL

OPTILOGG

Intervention Type: DEVICE

OPTILOGG is a CE marked class 1m medical device. It consists of a tablet computer and a wirelessly connected weight scale. The system will have some patient specific information regarding the flexible (loop-) diuretics scheme.

The patient will be asked to step on the weight scale daily, and will be shown to some brief information on how to live better with HF, as well as the recommended dose of diuretics that specific day. Every five days the patient will answer three questions about his/her symptoms, namely shortness of breath, fatigue and peripheral edema. The system also contains information that the patient can study at his/her leisure. If the system detects a deterioration in HF status, the patient is encouraged to contact his/her health care provider via telephone.

Interventions

OPTILOGG

OPTILOGG is a CE marked class 1m medical device. It consists of a tablet computer and a wirelessly connected weight scale. The system will have some patient specific information regarding the flexible (loop-) diuretics scheme.

The patient will be asked to step on the weight scale daily, and will be shown to some brief information on how to live better with HF, as well as the recommended dose of diuretics that specific day. Every five days the patient will answer three questions about his/her symptoms, namely shortness of breath, fatigue and peripheral edema. The system also contains information that the patient can study at his/her leisure. If the system detects a deterioration in HF status, the patient is encouraged to contact his/her health care provider via telephone.

Intervention Type: DEVICE

Standard care

Patients in the control group will be subject to standard heart failure care.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Sofia Gerward

Principal Investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sofia Gerward, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Region Skåne

Lund, Skåne County, Sweden

Countries

Sweden

Other Identifiers

SMART-HF

Identifier Type: -

Identifier Source: org_study_id