Self-efficacy, Beliefs and Adherence- Pilot and Feasibility Trial of a Pharmacist-led Intervention
- Conditions
- Diabetes Mellitus
- Interventions
- Other: Health literacy-psychosocial support
- Registration Number
- NCT03406923
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Health literacy-psychosocial support 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.)
- Primary Outcome Measures
Name Time Method Change in diabetes medication adherence 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.
Change in diabetes control 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
Name Time Method Experiences and perceptions of the intervention processes and outcomes 6 months after the intervention A phenomenological qualitative approach using semi-structured 60-minute in-depth interviews will be conducted with 15 intervention participants.
Illness beliefs 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.
Self-efficacy for medication use 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.
Beliefs in medicines 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.
Health literacy 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.
Trial Locations
- Locations (1)
William S. Middleton Memorial Veterans Hospital
🇺🇸Madison, Wisconsin, United States