SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure

NCT ID: NCT03162848

Last Updated: 2019-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Medication Adherence Heart Failure Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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SystemCHANGE intervention

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.

Group Type EXPERIMENTAL

SystemCHANGE

Intervention Type BEHAVIORAL

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.

Attention Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SystemCHANGE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri, Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Angela Andrews

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela Andrews, PhD(c)

Role: PRINCIPAL_INVESTIGATOR

University of Missouri, Kansas City

Locations

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Belleville Memorial

Belleville, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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17-130

Identifier Type: -

Identifier Source: org_study_id

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