Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00553

2 Trial Registration Date

2017-04-20

i Registration Status

Prospective

3 Secondary IDs

KW/FR-16-206(106-19)

4 Source(s) of Funding

NA

5 Primary Sponsor

SUM MING LEUNG

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

SUM MING LEUNG

ii Address

FLAT A, 12/F, BLOCK 2, CITYPOINT,
NO. 48 WING SHUN STREET,
TSUEN WAN,
HONG KONG

iii Phone

98606942

iv Email

samsumg@gmail.com

v Affiliation

THE NETHERSOLE SCHOOL OF NURSING, CHINESE UNIVERSITY OF HONG KONG

vi Country

HONG KONG

8 Research Contact Person (person to contact for scientific inquiries)

i Name

SUM MING LEUNG

ii Address

FLAT A, 12/F, BLOCK 2, CITYPOINT,
NO. 48 WING SHUN STREET,
TSUEN WAN,
HONG KONG

iii Phone

98606942

iv Email

samsumg@gmail.com

v Affiliation

THE NETHERSOLE SCHOOL OF NURSING, CHINESE UNIVERSITY OF HONG KONG

vi Country

HONG KONG

9 Official Scientific Title of the Study

The impact of Conversation Map Tool on self-efficacy and diabetes-specific health related quality of life in Chinese people with type 2 diabetes.

10 Public Title

The impact of Conversation Map Tool on self-efficacy and diabetes-specific health related quality of life in Chinese people with type 2 diabetes.

i Public Title in Chinese 研究名稱

探討糖尿病看圖對話教學工具對2型糖尿病病人之自我效能、自我管理行為之信心、健康質素及血糖控制之影響。

11 Short Title (Optional)

12 Countries of Recruitment

HONG KONG

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-01-26

iii Full Name of IRB/IEC

Kowloon West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

KW/FR-16-206(106-19)

14 Medical Condition Being Studied

TYPE 2 DIABETES

15 Intervention

i Types of intervention

Other

Please specify

Conversation Map Tool (CMT) Program

ii Description/ name of Intervention/article

The intervention for the experimental group is a CMT program consists of 4 CMT sessions conducted by CMT facilitators. Each session will last for 2 to 3 hours and the interval will be 1 to 2 weeks. The topics of CMT used are “Living with diabetes”, “Healthy eating and keeping active”, “Starting insulin treatment” and last session was “Understanding the many factors of managing diabetes”.

iii Dosage form of the intervention

2 to 3 hours CMT session

iv Dosage of the intervention

CMT sessions

v Duration of the intervention

4 CMT sessions within 6 weeks

vi Frequency of the intervention

1 to 2 weeks

16 Comparative Treatments

i Description/ name of comparative treatments

Four sessions of 1-hour didactic education will be designed for control group. Trained diabetes educator will conduct these sessions. It can served as an attentive intervention with similar contents and dose of intervention as compared with CMT program. It consists of “What is diabetes”, “Healthy diet and exercise”, “Medication for diabetes” and “Diabetes complications”.

ii Dosage form of the comparative treatments

1 hour didactic education

iii Dosage of the comparative treatments

Didactic education session

iv Duration of the comparative treatments

4 didactic education sessions within 6 weeks

v Frequency of the comparative treatments

1 to 2 weeks

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

People with type 2 diabetes with aged from 18 to 75.

People with type 2 diabetes have been diagnosed for at least 6 months. The diagnosis of diabetes is confirmed by a 2-hour plasma glucose of ≥ 11.1mmol/L in Oral Glucose Tolerance Test or Fasting plasma glucose ≥ 7.0 mmol/L

People with type 2 diabetes have suboptimal glycemic control (i.e., HbA1c >7%) in the past 6 months

People with type 2 diabetes are able to understand and answer the self-administered questionnaires.

ii Exclusion Criteria

Adult type 1 diabetes

People with type 2 diabetes have experience of attending CMT session.

People with type 2 diabetes with hearing impairment

People with type 2 diabetes with cognitive impairment as indicated by an Abbreviated Mental Test score of < 6 or psychiatric illness (e.g. schizophrenia) with unstable emotional state.

People with type 2 diabetes but unable to read Chinese

iii Age Minimum

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Block randomization with block size in one-to-one allocation ratio. A computer-generated random sequ

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-04-29

21 Target Sample Size

110

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Chinese version of Diabetes Management Self-Efficacy Scale (C-DMSES) and Chinese version of Diabetes Empowerment Scale-Short Form (C-DES-SF)

ii The metric or method of measurement used

Self-administered questionnaire

iii The timepoint(s) of primary interest

Baseline will be collected the start of intervention and randomization. Subsequent data collection by these 3 questionnaires will be collected at the time that immediately after the last intervention session, and 2 months thereafter.

24 Secondary Outcome

i The Name of the outcome

Glycated Hemoglobin A1c (HbA1c) and Chinese version of the EuroQoL-5D (C-EQ-5D-5L)

ii The metric or method of measurement used

HbA1c will be measured by high performance liquid chromatography by a machine called Premier Hb9210 HbA1c analyzer in Hospital Authority and Self-administered questionnaire

iii The timepoint(s) of primary interest

The HbA1c change will be evaluated 2-3 months after the completion Baseline will be collected the start of intervention and randomization. Subsequent data collection by these 3 questionnaires will be collected at the time that immediately after the last intervention session, and 2 months thereafter.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-07-03

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2017-04-20