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Trial History Detail on 2017-04-20

CUHK_CCRB00553

2017-04-20

Prospective

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

NA

SUM MING LEUNG

NA

Not Applicable

SUM MING LEUNG

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

98606942

samsumg@gmail.com

THE NETHERSOLE SCHOOL OF NURSING, CHINESE UNIVERSITY OF HONG KONG

HONG KONG

SUM MING LEUNG

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

98606942

samsumg@gmail.com

THE NETHERSOLE SCHOOL OF NURSING, CHINESE UNIVERSITY OF HONG KONG

HONG KONG

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

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

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。

HONG KONG

Yes

2017-01-26

Kowloon West Cluster Research Ethics Committee

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

TYPE 2 DIABETES

Other

Conversation Map Tool (CMT) Program

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”.

2 to 3 hours CMT session

CMT sessions

4 CMT sessions within 6 weeks

1 to 2 weeks

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”.

1 hour didactic education

Didactic education session

4 didactic education sessions within 6 weeks

1 to 2 weeks

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.

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

18

75

Both Male and Female

Interventional

Randomized

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

Active

Single-blind

Trial subjects

Parallel

0

2017-04-29

110

Not Yet Recruiting

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

Self-administered questionnaire

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.

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

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

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.

No

2017-07-03

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