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

Primary Purpose

Medication Adherence, Chronic Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Integrative Medication Self Management (IMedS) Intervention
Standard Care Educational Intervention
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medication Adherence focused on measuring occupational therapy, medication adherence, intervention studies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Occupational Therapy Intervention Group

    Standard Care Intervention Group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Medication Adherence
    Daily medication possession ratio via diary
    Self-perceived improvements in ability to mange medications
    Participants at the end of the study indicate if they believe that their ability to manage medications has improved, declined, or stayed the same.

    Secondary Outcome Measures

    Strategies used to manage medications
    Number of new strategies in daily life used to manage medications per participant report

    Full Information

    First Posted
    March 8, 2016
    Last Updated
    March 15, 2016
    Sponsor
    University of Wisconsin, Milwaukee
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02706548
    Brief Title
    Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence
    Acronym
    IMedS
    Official Title
    Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Wisconsin, Milwaukee

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Medication Adherence, Chronic Disease
    Keywords
    occupational therapy, medication adherence, intervention studies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Occupational Therapy Intervention Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard Care Intervention Group
    Arm Type
    Active Comparator
    Arm Description
    Thirty-minute educational intervention in which the participant and interventionist review a pamphlet on adherence to medication.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Integrative Medication Self Management (IMedS) Intervention
    Intervention Description
    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
    Intervention Name(s)
    Standard Care Educational Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Medication Adherence
    Description
    Daily medication possession ratio via diary
    Time Frame
    4 Weeks
    Title
    Self-perceived improvements in ability to mange medications
    Description
    Participants at the end of the study indicate if they believe that their ability to manage medications has improved, declined, or stayed the same.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Strategies used to manage medications
    Description
    Number of new strategies in daily life used to manage medications per participant report
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Single-subject data available in publications
    Citations:
    PubMed Identifier
    26539678
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27767947
    Citation
    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.
    Results Reference
    derived

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

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