Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence

NCT ID: NCT02706548

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-05-31

Brief Summary

Many persons with chronic health conditions fail to take their medications as prescribed, resulting in declines in health and function. Unfortunately, current interventions for medication nonadherence are not very effective. This objective of this study is to test a new intervention, the Integrative Medication Self-management (IMedS) intervention to improve medication adherence in adults with chronic health conditions.

Detailed Description

Many persons with chronic health conditions fail to take their medications as prescribed, resulting in declines in health and function. Objective: The purpose of this study was to perform a phase I feasibility study to understand if an integrated occupational therapy intervention could help people with chronic health conditions improve their adherence to medications. Method: Using a small-N design, we report single-subject analyses of the medication adherence, behavior counts, and perceptions of medication adherence of participants before and after either an occupational therapy intervention or standard of care intervention. We used a multiple baseline approach with inter-subject replication, and blinding.

Conditions

Medication Adherence; Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Occupational Therapy Intervention Group

Thirty-minute intervention in which the participant and interventionist discuss past medication taking performance, medication-related goals, and strategies to meet goals. Intervention is enhanced with motivational interviewing and therapeutic use of self.

Group Type: EXPERIMENTAL

Integrative Medication Self Management (IMedS) Intervention

Intervention Type: BEHAVIORAL

Half of participants received a manualized 30-minute occupational therapy intervention, Integrative Medication Self-Management Intervention (IMedS). During IMedS, the interventionist and client progress through three steps in which the pair: 1) reflect on past performance of medication management, 2) set a medication goal, and 3) generate strategies to reach the goal. During strategy generation, the interventionist uses therapeutic use of self and motivational interviewing to help the client self-generate new medication management strategies, specifically addressing 1) altering the activity, 2) advocacy, 3) education, 4) assistive technology, 5) environmental modifications, and 6) securing timely refills.

Standard Care Intervention Group

Thirty-minute educational intervention in which the participant and interventionist review a pamphlet on adherence to medication.

Group Type: ACTIVE_COMPARATOR

Standard Care Educational Intervention

Intervention Type: BEHAVIORAL

The standard care educational intervention was a 30-minute pamphlet based educational session. In the standard care intervention group, participants and interventionist first reviewed the pamphlet, Managing Your Medicines: Our Guide to Effective Medication Management (American Heart Association \& American Stroke Association, 2013). Then, the interventionist engaged in active listening, where she asked open-ended questions about the participant's medication routines and provided simple reflections. For the standard care procedures, the interventionist was prohibited from providing affirmations, complex reflections, summaries, problem-solving, or suggesting any specific interventions.

Interventions

Integrative Medication Self Management (IMedS) Intervention

Half of participants received a manualized 30-minute occupational therapy intervention, Integrative Medication Self-Management Intervention (IMedS). During IMedS, the interventionist and client progress through three steps in which the pair: 1) reflect on past performance of medication management, 2) set a medication goal, and 3) generate strategies to reach the goal. During strategy generation, the interventionist uses therapeutic use of self and motivational interviewing to help the client self-generate new medication management strategies, specifically addressing 1) altering the activity, 2) advocacy, 3) education, 4) assistive technology, 5) environmental modifications, and 6) securing timely refills.

Intervention Type: BEHAVIORAL

Standard Care Educational Intervention

The standard care educational intervention was a 30-minute pamphlet based educational session. In the standard care intervention group, participants and interventionist first reviewed the pamphlet, Managing Your Medicines: Our Guide to Effective Medication Management (American Heart Association \& American Stroke Association, 2013). Then, the interventionist engaged in active listening, where she asked open-ended questions about the participant's medication routines and provided simple reflections. For the standard care procedures, the interventionist was prohibited from providing affirmations, complex reflections, summaries, problem-solving, or suggesting any specific interventions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed with a chronic health condition
• Live in the community
• A medication regimen of 5 or more medications a day recommended by a health care professional
• Independently manage medications
• Difficulty taking medications as prescribed
• Live in the Milwaukee area

Exclusion Criteria

• Significant cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: lead

Responsible Party

Jaclyn Schwartz

Doctoral Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Schwartz JK, Smith RO. Benefits of Student Engagement in Intervention Research. Am J Occup Ther. 2015 Sep-Oct;69 Suppl 2:6912185050p1-6912185050p10. doi: 10.5014/ajot.2015.018200.

Reference Type: RESULT

PMID: 26539678 (View on PubMed)

Schwartz JK, Smith RO. Intervention Promoting Medication Adherence: A Randomized, Phase I, Small-N Study. Am J Occup Ther. 2016 Nov/Dec;70(6):7006240010p1-7006240010p11. doi: 10.5014/ajot.2016.021006.

Reference Type: DERIVED

PMID: 27767947 (View on PubMed)

Other Identifiers

15.048

Identifier Type: -

Identifier Source: org_study_id