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

NCT04698954 | Completed

• 1 other identifier: NL74248.091.20
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Medication adherence; Physical activity; Step count; Self-management; Behavioural intervention; Self-care; Symptom monitoring; Symptom management; Electronic monitoring

Outcome Measures

Primary Outcomes (1)

• Medication adherence

  Medication will be objectively assessed by a medication registration button, which is a medication event monitoring system (MEMS). The percentage of days with the correct amount of intakes, indicates the dosing adherence.

  12 months

Secondary Outcomes (8)

• Physical activity (SQUASH)

  Change from baseline, at 6 and 12 months follow-up

• Physical activity (SBQ)

  Change from baseline, at 6 and 12 months follow-up

• Physical activity (Garmin Vivofit 4) - number of steps

  Change from baseline (2 weeks prior intervention consult at 6 months), at 9 and 12 months follow up

• Physical activity (Garmin Vivofit 4) - active minutes

  Change from baseline (2 weeks prior intervention consult at 6 months), at 9 and 12 months follow up

• Physical activity (Garmin Vivofit 4)- moving distance

  Change from baseline (2 weeks prior intervention consult at 6 months), at 9 and 12 months follow up

Other Outcomes (1)

• Cardiac Event Free Survival

  Up to 1 year and 5 years follow up

Study Arms (2)

AIMS intervention group

EXPERIMENTAL

A nurse-delivered behavioural intervention focussing on medication adherence, physical activity, and symptom management integrated in routine clinical care. AIMS-CHF incorporates nurse-counselling and feedback from electronic monitoring of medication use (using MEMS-buttons) and physical activity (using pedometers).

Behavioral: Adherence Improving self-Management Strategy

Treatment-as-usual group

ACTIVE COMPARATOR

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

Other: Treatment-as-usual

Interventions

Adherence Improving self-Management Strategy BEHAVIORAL

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.

AIMS intervention group

Treatment-as-usual OTHER

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.

Treatment-as-usual group

Eligibility Criteria

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

You may qualify if:

• Diagnosed with Chronic Heart Failure (from either preserved or non-preserved systolic functions)
• New York Heart Association class II and III
• Able to understand and perform study related procedures
• Has an appointment at the HF clinic of at least once per 6 months

You may not qualify if:

• Unable to give informed consent
• New York Heart Association class I or IV
• Participation in another interventional study targeting medication adherence, physical activity, symptom monitoring, and/or diet.
• A coexisting imminently terminal illness, such as cancer or chronic renal failure requiring dialysis.
• Patients in titration phase (due to multiple changes in medication regimen)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Canisius-Wilhelmina Hospital: collaborator
• Maas Hospital Pantein: collaborator

Study Sites (3)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

CWZ

Nijmegen, Gelderland, 6532 SZ, Netherlands

Location

Maasziekenhuis Pantein

Beugen, North Brabant, 5835 DV, Netherlands

Location

MeSH Terms

Conditions

Heart Failure; Medication Adherence; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marijn de Bruin, prof. dr.

  Radboudumc, RIHS, IQ Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 7, 2021
• Study Start: December 14, 2020
• Primary Completion: February 3, 2023
• Study Completion: February 24, 2023
• Last Updated: June 15, 2023

Record last verified: 2020-12

Locations

NL (3)