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

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Other: Health literacy-psychosocial support

Study type

Interventional

Funder types

Other
Industry
Other U.S. Federal agency

Identifiers

NCT03406923
Protocol Version 3/27/2020 (Other Identifier)
2017-0951
PHARM/PHARMACY (Other Identifier)
A561000 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

31 participants in 2 patient groups

Usual care
No Intervention group
Description:
Receive usual care only.
Health literacy-psychosocial support
Experimental group
Description:
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.)
Treatment:
Other: Health literacy-psychosocial support

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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