Evaluating the Adherence Improving Self-Management Strategy Intervention in Chronic Heart Failure Patients

NCT04698954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2023-06-15

No results posted yet for this study

Summary

Patient non-adherence to treatment recommendations is common and decreases the effectiveness of Chronic Heart Failure (CHF) treatment. Improving adherence towards medication intake, physical activity, symptom monitoring/management might prolong life, alleviates symptoms, increases quality of life, and reduces hospital admissions. The Adherence Improving self-management Strategy (AIMS) is a nurse delivered intervention, integrated in routine clinical care, aiming to better support patients in their treatment. AIMS has previously been demonstrated to be (cost) effective amongst HIV patients. Based on the literature and advisory boards with healthcare providers and CHF patients, AIMS is adapted to CHF (AIMS-CHF).

The aim of the study is to evaluate the effectiveness of the AIMS intervention on adherence regarding medication, physical activity, and symptom management compared to treatment-as-usual in patients with chronic heart failure.

Conditions

  • Chronic Heart Failure
  • Heart Decompensation
  • Myocardial Failure
  • Preserved Ejection Fraction
  • Reduced Ejection Fraction

Interventions

BEHAVIORAL

Adherence Improving self-Management Strategy

The AIMS intervention is a conversation between a patient and a trained nurse, imbedded in the usual care. It consists of structured modules with visual materials, developed based on a sound understanding of the factors that drive non-adherence and potent behaviour change techniques to modify those. These modules aim to enhance patient knowledge, motivation, self-efficacy, and skills for self-managing their treatment. As part of the intervention, patients use electronic monitors to track their own behaviour, namely a medication and a physical activity monitor. Together with the nurse they examine these results to identify adherence problems and solutions and make a plan.

OTHER

Treatment-as-usual

Participants in the control group will receive treatment as usual. They will visit the nurse in the out patient clinic each 3 or 6 months for 30 minutes.

Sponsors & Collaborators

  • Canisius-Wilhelmina Hospital

    collaborator OTHER
  • Maas Hospital Pantein

    collaborator OTHER
  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Marijn de Bruin, prof. dr. · Radboudumc, RIHS, IQ Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2023-02-03
Completion
2023-02-24

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698954 on ClinicalTrials.gov