NCT03162848

Brief Summary

The purpose of this pilot RCT study is to evaluate the acceptability and feasibility of a SystemCHANGE™ intervention to improve medication adherence in older adults with heart failure. The intervention focuses on changing the individual's environment by incorporating medication taking into existing routines using small experiments with feedback, and receiving support from people who impact routines.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

8 months

First QC Date

May 11, 2017

Last Update Submit

May 24, 2019

Conditions

Medication AdherenceHeart FailureAging

Outcome Measures

Primary Outcomes (1)

  • Acceptability and feasibility using open ended questionnaire

    open ended questionnaire asking participants about acceptability and feasibility

    one point in time at the end of the maintenance phase which is 3 months after randomization into groups

Secondary Outcomes (3)

  • Systems thinking using questionnaire

    baseline and after 2 month intervention phase

  • Kansas City Cardiomyopathy Questionnaire

    baseline and after 2 month intervention phase

  • Medication adherence using medication event monitoring systems

    after randomization through end of maintenance phase for a total of 3 months

Study Arms (2)

SystemCHANGE intervention

EXPERIMENTAL

The SystemCHANGE™ intervention utilizes the Socioecological Model and Plan-Do-Check Act model as its framework and focuses on changing the individual's environment to change behavior using small experiments with feedback.

Behavioral: SystemCHANGE

Attention Control

NO INTERVENTION

The attention control group will receive education at baseline, 1 month, and 2 months following America Heart Association brochures.

Interventions

SystemCHANGEBEHAVIORAL

At initial home visit, the PI will work with the participant to identify important people for medication taking, routines, and cycles of routines. Possible solutions to incorporate medication taking into routines will be identified by the participant and PI and the participant will start implementing these solutions. Medication adherence will continuously be monitored using medication event monitoring systems. At one month, the participant will be sent a report on medication taking and a phone call will occur with the PI to discuss if solutions improved medication adherence or if other solutions need to be implemented. At month two, the intervention will end but participants are urged to continue to use solutions long term.

SystemCHANGE intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 50 years or older
  • HF diagnosis confirmed by their physician utilizing their most recent ejection fraction
  • prescribed diuretics
  • self-administering medications
  • able to open an electronic cap
  • able to speak, hear and understand English
  • not hospitalized,
  • no cognitive impairment as determined by a score of 4 or greater on the 6-item mini-mental status exam.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belleville Memorial

Belleville, Illinois, 62225, United States

Location

MeSH Terms

Conditions

Medication AdherenceHeart Failure

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHeart DiseasesCardiovascular Diseases

Study Officials

  • Angela Andrews, PhD(c)

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 22, 2017

Study Start

September 1, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 28, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)