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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03406923
• Other study ID #: 2017-0951
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	William S. Middleton Memorial Veterans Hospital	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Merck Sharp & Dohme Corp., William S. Middleton Memorial Veterans Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diabetes medication adherence	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.	Baseline, 3 months, and 6 months after the intervention
Primary	Change in diabetes control	Hemoglobin A1c will be abstracted from electronic medical records using the most recent value for each participant within the prior six months.	Baseline and 6 months after the intervention
Secondary	Self-efficacy for medication use	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.	Baseline, 6 weeks, and 3 months after the intervention
Secondary	Illness beliefs	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.	Baseline, 6 weeks, and 3 months after the intervention
Secondary	Beliefs in medicines	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.	Baseline, 6 weeks, and 3 months after the intervention
Secondary	Health literacy	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.	Baseline and 6 months after the intervention
Secondary	Experiences and perceptions of the intervention processes and outcomes	A phenomenological qualitative approach using semi-structured 60-minute in-depth interviews will be conducted with 15 intervention participants.	6 months after the intervention