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N/A N=169 Randomized Double-blind Health Services Research

An Educational Intervention for Type 2 Diabetes Patients

Diabetes Mellitus

Enrolled (actual)
169
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Patients' Perceived Self-efficacy to Communicate — 22.11; 22.14; 23.44; 22.63 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Intervention Video (Behavioral); Control (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Nov 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Patients' Perceived Self-efficacy to Communicate
22.11; 22.14; 23.44; 22.63
PRIMARY
Patients Active Participatory Communication Behaviors
41.96; 44.32; 43.02; 42.92
SECONDARY
Medication Adherence
82.66; 78.78; 3.26; 3.23
SECONDARY
Hemoglobin A1c
10.07; 9.53; 9.07; 9.27

Summary

Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the prevalence of diabetes at almost 20 percent in VA patients and the prevalence of diabetes in the VA is higher among racial and ethnic minorities. Poorly controlled diabetes leads to a number of complications including cardiovascular disease, blindness, amputation, and end stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care is related at least in part to effective communication in medical encounters. This project is designed to test a video intervention to improve patients' communication behaviors. Doctors will also receive a communication skills training program. The project will assess the impact of the training programs on communication and outcomes. The study is designed to help make patient care more patient-centered, which is one of the six aims for improvement in the Institute Of Medicine report, Crossing the Quality Chasm and is a goal of VA transformation efforts.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of type 2 diabetes mellitus
  • Hemoglobin A1c (HgbA1c) greater than or equal to 8
  • Adults, age 18 or older

Exclusion Criteria

  • Lives in skilled nursing facility
  • Dementia (abnormal score on Mini-COG)
  • Terminal medical condition
  • Drug- (e.g., steroid) induced diabetes.
  • Blind or deaf (e.g., unable to view/hear video)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01671345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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