NCT02977130

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
615

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable diabetes-mellitus

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

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

November 24, 2016

Last Update Submit

November 29, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Diet- and exercise-related health behaviors

    3 months

  • Glycated hemoglobin (HbA1c)

    3 months

Study Arms (2)

Map group

EXPERIMENTAL

patients receiving general shared care for diabetes and the conversation map intervention

Behavioral: Map group

Control group

ACTIVE COMPARATOR

patients receiving general shared care for diabetes

Behavioral: Control group

Interventions

Map groupBEHAVIORAL

diabetes shared care plus conversation map intervention

Map group
Control groupBEHAVIORAL

diabetes shared care

Control group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusBehaviorHealth Behavior

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jiun-Hau Huang, SM, ScD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

November 30, 2016

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 30, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share