An Educational Intervention for Type 2 Diabetes Patients

NCT01671345 | Completed Results

• 1 other identifier: IIR 12-050
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Patients' Perceived Self-efficacy to Communicate

  Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians.

  at the baseline ( Visit 1) and post-intervention (Visit 2)

• Patients Active Participatory Communication Behaviors

  Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits. Active participatory communication behaviors include four essential elements: 1. telling a medical history; 2. asking questions; 3. being assertive or making requests, and 4. communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication.

  at the baseline ( Visit 1) and post-intervention (Visit 2)

Secondary Outcomes (2)

• Medication Adherence

  Four weeks post-intervention (i.e. four weeks after Visit 2).

• Hemoglobin A1c

  At the baseline (Visit 1) and post-intervention (after Visit 2). All available values were restricted to one year before Visit 1 and from 30 days to one year past Visit 2.

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Patients randomized to the intervention will view the intervention video

Behavioral: Intervention Video

Control

PLACEBO COMPARATOR

Patients randomized to control will view an informative video about nutrition and exercise of similar length

Behavioral: Control

Interventions

Intervention Video BEHAVIORAL

A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence

Also known as: Speak Up!

Intervention

Control BEHAVIORAL

Attention control

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Gordon HS, Street RL. How Physicians, Patients, and Observers Compare on the Use of Qualitative and Quantitative Measures of Physician-Patient Communication. Eval Health Prof. 2016 Dec;39(4):496-511. doi: 10.1177/0163278715625737. Epub 2016 Jan 10.

  PMID: 26755527 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The analysis of communication outcomes is not yet complete because of delays in coding of transcribed audio-recordings.

Results Point of Contact

• Title: Howard S. Gordon, MD
• Organization: Jesse Brown VA Medical Center

howard.gordon2@va.gov

312-569-7331

Study Officials

• Howard S. Gordon, MD SB

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: August 23, 2012
• Study Start: November 27, 2013
• Primary Completion: November 30, 2016
• Study Completion: January 9, 2017
• Last Updated: March 11, 2019
• Results First Posted: March 11, 2019

Record last verified: 2018-11

Locations

US (1)