Selfcare Management Intervention in Heart Failure

NCT03484286 | Completed

• 1 other identifier: SMART-HF
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of HF related days in the hospital

  Eight months

• Event-free survival

  Eight months

Other Outcomes (3)

• Number of HF admissions

  Eight months

• Number of ER-visits

  Eight months

• Adherence to the intervention

  Eight months.

Study Arms (2)

Control group

OTHER

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.

Other: Standard care

Intervention group

EXPERIMENTAL

Device: OPTILOGG

Device: OPTILOGG

Interventions

OPTILOGG 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.

Intervention group

Standard care OTHER

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

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Region Skane: collaborator

Study Sites (1)

Region Skåne

Lund, Skåne County, 22185, Sweden

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sofia Gerward, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Cardiovascular events will be adjudicated as heart failure related or not. Data analysis will be performed by staff blinded to the patients IDs.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: Parallell randomized clinical trial with continuous sampling and a 1:1 randomization.

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 30, 2018
• Study Start: April 3, 2018
• Primary Completion: October 18, 2019
• Study Completion: December 13, 2019
• Last Updated: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)