NCT03406923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

December 4, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

December 28, 2017

Last Update Submit

February 11, 2021

Conditions

Diabetes Mellitus

Keywords

Health literacySelf-efficacyBeliefs about diabetesBeliefs in medicines

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Self-efficacy for medication use

    Baseline, 6 weeks, and 3 months after the intervention

  • Illness beliefs

    Baseline, 6 weeks, and 3 months after the intervention

  • Beliefs in medicines

    Baseline, 6 weeks, and 3 months after the intervention

  • Health literacy

    Baseline and 6 months after the intervention

  • Experiences and perceptions of the intervention processes and outcomes

    6 months after the intervention

Study Arms (2)

Usual care

NO INTERVENTION

Receive usual care only.

Health literacy-psychosocial support

EXPERIMENTAL

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

Interventions

Health literacy-psychosocial supportOTHER

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.

Health literacy-psychosocial support

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William S. Middleton Memorial Veterans Hospital

Madison, Wisconsin, 53705, United States

Location

Related 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. doi: 10.1016/S0149-2918(99)80026-5.

    PMID: 10440628BACKGROUND

  • 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.

    PMID: 21473660BACKGROUND

  • 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.

    PMID: 26341940BACKGROUND

  • 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.

    PMID: 26652095BACKGROUND

  • 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.

    PMID: 22999805BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Olayinka Shiyanbola, PhD, BPharm

    School of Pharmacy, University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 23, 2018

Study Start

December 4, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)