Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02274844
Other study ID # PCORI-R-AD-1306-03565
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date January 31, 2019

Study information

Verified date October 2020
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care.


Description:

Improving medication adherence is one of the greatest challenges in modern medicine. Despite decades of research on the topic, as many as half of patients with chronic diseases are not taking medications as recommended, and costs of nonadherence have been estimated at $290 billion annually. One reason for this persistent finding could be that interventions rarely acknowledge medications within the larger context of the lived experience of illness. Drawing on hundreds of patient interviews, Corbin and Strauss showed that chronic illness is a fundamentally destabilizing influence that forces us to confront the potential limitations of our "new", chronically ill self. Accepting our illness may be a crucial step in embracing medication adherence and other self-management behaviors as ways to restore balance following this disruption. The Corbin and Strauss framework is not often used to develop and test interventions to improve medication adherence, and this is the central objective of this proposal. Medication adherence is especially critical in regions like rural Alabama, where residents have among the worst health outcomes in the US. Rates of cardiovascular mortality, diabetes and obesity are very high, but resources are scarce and the area's predominately black residents have deep-seated mistrust of the healthcare system (the region includes Tuskegee, site of the infamous syphilis study). This project was designed in collaboration with our community member partners and builds on a 5-year partnership of community-engaged research on diabetes peer coaching interventions and our experience with peer storytelling. The investigators will test the hypothesis that an intervention designed within the Corbin and Strauss framework can improve adherence and health outcomes compared to usual care. Our Aims are: Aim 1: With our community partners, using qualitative research methods, build on already developed culturally tailored education material to develop the medication adherence intervention. The intervention will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching. Activities include conducting focus groups with patients; creating the DVDs and the coaching intervention protocol; training peer coaches; and pilot testing. Aim 2: Conduct a randomized controlled trial with 500 individuals with type 2 diabetes and medication nonadherence. The trial will compare the effect of usual care and the intervention on medication adherence and physiologic risk factors including A1c, blood pressure and low density lipoprotein cholesterol (primary outcomes), and quality of life and self-efficacy (secondary outcomes). This innovative approach would be a major shift in how patients are helped in under resourced areas living with chronic diseases commit to taking medications, improving health and eventually reducing health disparities.


Recruitment information / eligibility

Status Completed
Enrollment 473
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - adults - type 2 diabetes - taking medications for diabetes - medication non adherent Exclusion Criteria: - nursing home residence - plans to move away in the next year - advanced illnesses such as hemodialysis, cancer or dementia

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Living Well with Diabetes Program
The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching

Locations

Country Name City State
United States Univeristy of Alabama at Birmingham Birmingham Alabama

Sponsors (3)

Lead Sponsor Collaborator
Weill Medical College of Cornell University Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Medication Beliefs- Harm (Beliefs That Medications Are Harmful) Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. Baseline, 6 months
Other Change in Medication Beliefs- Overuse (Concerns About the Way Doctors Use Medications) Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. Baseline, 6 months
Other Change in Medication Beliefs-Necessity (Beliefs About the Necessity of Medications) Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. Baseline, 6 months
Other Change in Medication Beliefs- Concerns (Concerns About the Negative Effects of Medications) Beliefs about medications questionnaire scores range from 5-25; higher scores indicate stronger beliefs. Baseline, 6 months
Primary Change in Self Reported Medication Adherence Patient-reported adherence to medications as a medication adherence score, from 0-3, where a higher score indicates worse adherence. Baseline, 6 months
Primary Change in Percentage of HbA1c Hemoglobin A1c test to identify the average amount of glucose (sugar) present in a patient's blood. Baseline, 6 months
Primary Change in Blood Pressure 2 BP measures were taken 1 minute apart using a LifeSource UA-789 digital blood pressure monitor. Baseline, 6 months
Primary Change in Low-Density Lipoprotein (LDL) Cholesterol Finger stick, spectrophotometer to measure cholesterol level. Baseline, 6 months
Secondary Change in Quality of Life as Assessed With the Short Form 12- Mental Component Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life. Baseline, 6 months
Secondary Change in Quality of Life as Assessed With the Short Form-12- Physical Component Short Form-12 Mental Component and Physical Component Summary scores range from 0-100; higher scores indicate greater quality of life. Baseline, 6 months
Secondary Change in Medication Use Self-efficacy Score as Measured by SEAMS Scale and the Perceived Diabetes Self-Management Scale, Which is Associated With A1c Medication use self-efficacy scores for range from 13-39; higher scores indicate higher levels of self-efficacy for medication adherence. Baseline, 6 months
Secondary Change in Diabetes-Specific Quality of Life Diabetes specific quality of life will be assessed using the validated Diabetes Distress Scale.The DDS is a 17-item instrument that measures diabetes-related emotional distress. Participants rate the degree to which each item is problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). A score of 3 or greater = moderate distress. Baseline, 6 months
Secondary Number of Physician Office Visits 6 Months 6 months
Secondary Number of Hospital Stays at 6 Months 6 months
Secondary Number of Emergency Visits at 6 Months 6 months
Secondary Change in Diabetes Medication Counts Change in number of diabetes medications. Baseline, 6 months
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A