NCT02733315

Brief Summary

The Diabetes Conversation Map Program (DCMP) is a novel, group-based, interactive diabetes management education program that has been shown to help patients adapt to their disease. So the investigators aimed to examine the long-term effectiveness of the DCMP among diabetes patients in Taiwan.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

April 1, 2016

Last Update Submit

April 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weekly self-monitoring of blood glucose times as determined by medical chart review

    Up to nine months

Secondary Outcomes (5)

  • Body mass index as determined by medical chart review

    Up to nine months

  • The depressive symptoms level as measured by Taiwanese Depression Questionnaire

    Up to nine months

  • Level of DM health literacy as measured by the self-developed questionnaire

    Up to nine months

  • HbA1c as determined by medical chart review

    Up to nine months

  • fasting plasma glucose as determined by medical chart review

    Up to nine months

Study Arms (1)

DCMP

EXPERIMENTAL
Behavioral: Diabetes Conversation Map Program

Interventions

The experiment group received seven DCMP-based group education sessions for seven consecutive weeks in addition to routine health education at a private room in the outpatient unit. One registered nurse who received DCMP facilitator training, from the Taiwanese Association of Diabetic Educators, served as the class facilitator. DCMP sessions were conducted using seven colored "maps" covering different topics, including "walk with diabetes," "what is diabetes?", "a healthy diet and exercise," "walk with insulin," "diabetes complications and related risk factors," "foot care for diabetes patients," and "a type 1 diabetes patient in the home." Each map, a laminated 3-by-5-foot table-top visual with colorful drawings as metaphors of situations familiar to DM patients, was placed on a table with participants gathered around it. This procedure served to create mutual imagery to be shared with participants.

DCMP

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being at least 20 years old at the time of recruitment,
  • having no cognitive impairment and severe complications,
  • being able to express opinions in either Mandarin or Taiwanese, and
  • having a diagnosis of DM.

You may not qualify if:

  • being unwillingness to participant this work
  • Attending the similar health education program in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Researcher

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 11, 2016

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 12, 2016

Record last verified: 2016-04