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Self-efficacy, Beliefs and Adherence- Pilot and Feasibility Trial of a Pharmacist-led Intervention

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ClinicalTrials.gov Identifier: NCT03406923
Recruitment Status : Suspended (due to COVID-19)
First Posted : January 23, 2018
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
William S. Middleton Memorial Veterans Hospital
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This study uses an intervention mixed methods design. The overall purpose is to improve medication adherence and assess the clinical impact on diabetes outcomes among patients with uncontrolled diabetes. We will examine if usual care combined with a clinic-based health literacy/psychosocial support intervention improves medication adherence compared to usual care alone. A randomized controlled trial will be conducted at William S. Middleton Memorial Veterans Hospital in Madison, targeting individuals with uncontrolled diabetes. The patient-centered health literacy intervention will focus on enhancing patients' self-efficacy and addressing patients' negative beliefs in medicine and illness.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Health literacy-psychosocial support Not Applicable

Detailed Description:

The study will improve medication adherence for patients with diabetes using two strategies: 1) addressing health literacy by reducing the complexity of diabetes content disseminated to patients during medication counseling and 2) addressing health literacy by enhancing patient-pharmacist communication. The second strategy aims to improve the psychosocial support offered to patients by building self-efficacy and addressing negative beliefs about medicines and diabetes. Together, the patient and the pharmacist can work together towards goal setting, problem solving, and negotiation of competing priorities.

Currently, with usual care, the pharmacist confirms if patients understand how to take medications correctly, adjusts diabetes medications, and monitor patients' hemoglobin A1C levels periodically to make sure that patients are capable of managing their diabetes appropriately. With the proposed intervention, the pharmacist will identify patients' concerns and barriers to medication taking and self-care with diabetes with an emphasis on self-efficacy, negative beliefs in medicine and illness. Then the pharmacist will provide individualized plans and set specific goals with each patient by strengthening their confidence in medication use and health literacy skills in navigating health information for diabetes self-care. The methods described for the intervention are in line with the current clinic workflow and will not require a substantial change to the current system for counseling diabetes patients. Knowledge change often does not lead to behavior change. Hence, the intervention will innovatively focus on moving knowledge towards action as the clinical pharmacist works with patients in assessing health literacy, identifying their barriers to medication use, including lack of self-efficacy, addressing negative beliefs about diabetes and diabetes medications; towards problem solving, and developing goals and action plans that will improve medication adherence and glycemic control.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Self-efficacy, Beliefs and Adherence- Pilot and Feasibility Trial of a Pharmacist-led Intervention
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
No Intervention: Usual care
Receive usual care only.
Experimental: Health literacy-psychosocial support
Receive 6-week sessions of individual health literacy-psychosocial support in addition to usual care. The health literacy-psychosocial support intervention includes 45-minute face-to-face counseling at week 1 and week 6 as well as weekly phone calls (week 2 to week 5.)
Other: Health literacy-psychosocial support
The intervention is based upon enhancing patient health literacy-related attributes by (1) addressing the barriers to patients' self-efficacy by working with the patient to minimize the barriers (2) clarifying the patient beliefs about diabetes and diabetes medications, and (3) developing personalized action plans. We will tailor the intervention to each patient, so, the details of the content of each session will depend on the individual's self-efficacy, beliefs in illness and medicines, and health literacy level obtained at baseline. In addition to the 45-minute scheduled sessions, patients will be able to call the clinical pharmacist on the phone during the 6-week session at their discretion, for patient-driven support for self-management of goals and skills.




Primary Outcome Measures :
  1. Change in diabetes medication adherence [ Time Frame: Baseline, 3 months, and 6 months after the intervention ]
    Proportion of days covered and the 5-item Medication Adherence Rating Scale (MARS-5) will be used to measure diabetes medication adherence. The minimum score for the MAR scale is 5 and the maximum score is 25. Total score ranges from 5-25; Higher scores represent higher self-reported adherence.

  2. Change in diabetes control [ Time Frame: Baseline and 6 months after the intervention ]
    Hemoglobin A1c will be abstracted from electronic medical records using the most recent value for each participant within the prior six months.


Secondary Outcome Measures :
  1. Self-efficacy for medication use [ Time Frame: Baseline, 6 weeks, and 3 months after the intervention ]
    Self-efficacy for medication use will be measured using the 13-item Self-efficacy for Appropriate Medication Use Scale. The minimum score is 13 and the maximum score is 39. Higher scores represent higher confidence in adhering to medication use.

  2. Illness beliefs [ Time Frame: Baseline, 6 weeks, and 3 months after the intervention ]
    Illness beliefs will be measured using the 9-item the Brief Illness Perception Questionnaire. A higher score indicates a more threatening view of the illness. Total score ranges from 0-80.

  3. Beliefs in medicines [ Time Frame: Baseline, 6 weeks, and 3 months after the intervention ]
    Beliefs in medicines will be measured using the 10-item Belief about Medicines Questionnaire. The 10-item Belief about Medicines Questionnaire (BMQ) has the necessity beliefs and concern beliefs sub-scale (five items each). The scale has five-point Likert-type responses ranging from strongly disagree to strongly agree. Each sub-scale has scores ranging from 5-25, with a higher score meaning stronger concern or necessity beliefs about the medicine.

  4. Health literacy [ Time Frame: Baseline and 6 months after the intervention ]
    Health literacy will be measured using the 6-item Newest Vital Sign. Each question will be scored "0" for incorrect and "1" for correct yielding a total score ranging from 0 to 6, with higher scores indicating better health literacy. Scores less than 2 represented a high likelihood (50% or more) of limited (inadequate) health literacy, 2 to 3 indicated the possibility of limited (marginal) health literacy, and more than 3 suggested adequate health literacy.

  5. Experiences and perceptions of the intervention processes and outcomes [ Time Frame: 6 months after the intervention ]
    A phenomenological qualitative approach using semi-structured 60-minute in-depth interviews will be conducted with 15 intervention participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking men and women 18-80 years old with diabetes
  • Taking oral diabetes medications and/or insulin
  • One hemoglobin A1C measure of 8% or greater in the last 18 months
  • A score less than 25 on the Medication Adherence Rating Scale (MARS-5)

Exclusion Criteria:

  • Unable to provide informed consent
  • Younger than 18 years old or older than 80 years old
  • Unable to understand English
  • Do not take oral diabetes medications and/or insulin
  • A score equal to 25 on the Medication Adherence Rating Scale (MARS-5)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406923


Locations
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United States, Wisconsin
William S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Merck Sharp & Dohme Corp.
William S. Middleton Memorial Veterans Hospital
Investigators
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Principal Investigator: Olayinka Shiyanbola, PhD, BPharm School of Pharmacy, University of Wisconsin, Madison
Publications:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03406923    
Other Study ID Numbers: 2017-0951
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Health literacy
Self-efficacy
Beliefs about diabetes
Beliefs in medicines