Clinical trial NCT03406923: Self-efficacy, Beliefs and Adherence- Pilot and Feasibility Trial of a Pharmacist-led Intervention
Official title: Self-efficacy, Beliefs and Adherence- Pilot and Feasibility Trial of a Pharmacist-led Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Health literacy
Self-efficacy
Beliefs about diabetes
Beliefs in medicines
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: William S. Middleton Memorial Veterans Hospital
First posted: 2018-01-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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)

Primary outcomes:
measure: Change in diabetes medication adherence
timeFrame: Baseline, 3 months, and 6 months after the intervention
measure: Change in diabetes control
timeFrame: Baseline and 6 months after the intervention
Secondary outcomes:
measure: Self-efficacy for medication use
timeFrame: Baseline, 6 weeks, and 3 months after the intervention
measure: Illness beliefs
timeFrame: Baseline, 6 weeks, and 3 months after the intervention
measure: Beliefs in medicines
timeFrame: Baseline, 6 weeks, and 3 months after the intervention
measure: Health literacy
timeFrame: Baseline and 6 months after the intervention
measure: Experiences and perceptions of the intervention processes and outcomes
timeFrame: 6 months after the intervention
Other outcomes:
Locations:
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital
state: Wisconsin
Study officials:
affiliation: School of Pharmacy, University of Wisconsin, Madison
name: Olayinka Shiyanbola, PhD, BPharm
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farmer KC. Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther. 1999 Jun;21(6):1074-90; discussion 1073. doi: 10.1016/S0149-2918(99)80026-5.
citation: Keogh KM, Smith SM, White P, McGilloway S, Kelly A, Gibney J, O'Dowd T. Psychological family intervention for poorly controlled type 2 diabetes. Am J Manag Care. 2011 Feb;17(2):105-13.
citation: Lee YJ, Shin SJ, Wang RH, Lin KD, Lee YL, Wang YH. Pathways of empowerment perceptions, health literacy, self-efficacy, and self-care behaviors to glycemic control in patients with type 2 diabetes mellitus. Patient Educ Couns. 2016 Feb;99(2):287-94. doi: 10.1016/j.pec.2015.08.021. Epub 2015 Sep 2.
citation: Unni E, Shiyanbola OO, Farris KB. Change in Medication Adherence and Beliefs in Medicines Over Time in Older Adults. Glob J Health Sci. 2015 Sep 1;8(5):39-47. doi: 10.5539/gjhs.v8n5p39.
citation: Shiyanbola OO, Farris KB, Chrischilles E. Concern beliefs in medications: changes over time and medication use factors related to a change in beliefs. Res Social Adm Pharm. 2013 Jul-Aug;9(4):446-57. doi: 10.1016/j.sapharm.2012.07.003. Epub 2012 Sep 19.