The Influence of Conversation Map on the Health Behaviors of Diabetes Patients

November 29, 2016 updated by: National Taiwan University Hospital
The American Diabetes Association indicates that diabetes self-management is a skill that diabetic patients must learn in the Diabetes Self-Management Education; thus, this contributes to shared care for diabetes, in which teams of physicians, professional nurses, and dietitians offer shared care to patients. However, according to the statistical analysis of the conditions of glycemic control in diabetic patients in 28 countries across 4 continents (Asia, Africa, Europe, and South America), the mean glycated hemoglobin (HbA1c) of the 12,727 patients was 9.5% by Litwak et al. in 2013. In Taiwan, a national survey among diabetic patients in a shared-care program found that the percentage of patients with HbA1c lower than 7% increased by 6.5% from 2006 to 2011; yet, among the 720 patients who completed both surveys in 2006 and 2011, the percentage with HbA1c lower than 7% decreased by 2.1% during that period. These results suggest that despite the increase in the proportion of patients who successfully managed their diabetes, some patients still encountered difficulty in glycemic control.Therefore, numerous health education tools on diabetes continue to be developed. In 2011,JoAnn et al. determined that the mode of health care had a substantial influence on the dietary habits of diabetic patients, and that individual health education had the largest effect on diabetes control. In addition, using the conversation map for diabetes control also had a substantial influence on improving health behaviors. Among existing studies that have adopted the conversation map, no large-scale research has been conducted, the research samples and relevant studies in Taiwan have been scant, and no theoretical foundation has been applied in evaluating the effects of the conversation map. Accordingly, the investigators aimed to enhance the mutual experience exchange and learning among diabetic patients through adopting the conversation map to observe its influence on their health behaviors by incorporating it into existing health education modalities. Furthermore, on the basis of the Health Belief Model, a relevant questionnaire was designed for assessing the effectiveness of glycemic control in diabetic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

615

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus between 30 and 80 years of age who participated in a diabetes shared-care program.

Exclusion Criteria:

  • Patients were excluded if they had renal insufficiency (eGFR <30 mL•min / 1.732), were not ambulatory, or were unable to answer the questionnaire independently.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Map group
patients receiving general shared care for diabetes and the conversation map intervention
Behavioral: Map group
diabetes shared care plus conversation map intervention
Active Comparator: Control group
patients receiving general shared care for diabetes
Behavioral: Control group
diabetes shared care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycated hemoglobin (HbA1c)
Time Frame: 3 months
3 months
Diet- and exercise-related health behaviors
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Ministry of Science and Technology, Taiwan

Investigators

  • Principal Investigator: Jiun-Hau Huang, SM, ScD, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201404062RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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