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Completed

NCT Number: NCT03551925

Effect of Occupational Therapy in Promoting Medication Adherence

The purpose of this research study is to see if an occupational therapist can help people with high blood pressure and/or diabetes find ways to better take their medicine. Participants will be recruited from the Jordan Valley Community Health Center in Springfield, Missouri.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan Valley Community Health Center

Springfield, Missouri, 65806, United States

About this study

The purpose of this study is to determine whether the addition of an occupational therapy intervention to counseling by a clinical pharmacist (current usual care) compared to counseling by a clinical pharmacist only, will affect three-month medication adherence rates among community-dwelling adults with uncontrolled hypertension and/or diabetes.

To meet this purpose, the following objectives will be addressed:

  • to determine if the addition of the delivery of an occupational therapy intervention (specifically the Integrative Self-Management Intervention) to usual care improves three-month medication adherence rates, as measured by the Adherence to Refills and Medication Scale (ARMS-7), pill count, blood pressure and/or hemoglobin A1c.
  • to determine whether the administration of the occupational therapy intervention in addition to usual care influences an individual's readiness for change as measured by the stages of change measure; and
  • to explore whether participant demographics (e.g., gender, age, race/ethnicity, assist at home, co-morbidities, and number of medications) impact three-month medication adherence rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Jordan Valley Community Health Center clients will be considered eligible for inclusion in the study if they are 18 years or older, have a confirmed diagnosis of hypertension, receive a score of less than or equal to 21 on the Adherence to Refills and Medication Scale (ARMS-7) and they provide written informed consent.

Exclusion criteria

  • Participants will be excluded if they indicate via self-report that they are unable to read or understand spoken English without an interpreter or translator or if they have a medical power of attorney and are unable to provide their own informed consent.

Treatment and study plan

Treatment as Usual Plus Occupational Therapy

Behavioral

The IMeds consists of a three-step process that leads the client from the reflection of past performance, to goal setting, and onto strategy identification and implementation. This intervention guides the client through identifying strategies in the following six areas: altering the medication management activity, advocacy, assistive technology, environmental modifications, and securing refills on time (Schwartz et al., 2017).

Other names: IMeds

Treatment as Usual

Behavioral

A clinical pharmacist counsels participants on proper medication adherence.

Primary outcomes

  1. Change in Adherence to Refills and Medication Scale (Seven-item) (ARMS-7) Score

    Time frame: The ARMS-7 will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.

    The ARMS-7 consists of seven questions that provide a self-report of medication adherence.

Secondary outcomes

  1. Change in Stages of Change Measure Score

    Time frame: The stages of change measure will be given approximately every 4 weeks over a 12 week period by the clinical pharmacist.

    A single-item multiple choice question that assesses an individuals current readiness for change.

  2. Change in Pill count

    Time frame: Pill count will be completed approximately every 4 weeks over a 12 week period by the clinical pharmacist.

    A percentage of adherence can be calculated by pill count which includes dividing the number of doses taken by the number of doses that should have been taken multiplied by 100.

  3. Change in Blood pressure

    Time frame: Blood pressure will be taken approximately every 4 weeks over a 12 week period by the clinical pharmacist.

    Use of the manual auscultatory method for taking blood pressure will be completed by the clinical pharmacist. Systolic and diastolic blood pressures will be recorded and compared separately.

Sponsors and collaborators

Lead sponsor

University of Indianapolis

Other

Collaborators

  • Missouri State University
  • University of Missouri, Kansas City

Registry information

Official study title

Effect of Occupational Therapy in Promoting Medication Adherence: A Randomized Control Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 11, 2018
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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