Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00361

2 Trial Registration Date

2013-01-29

i Registration Status

Prospective

3 Secondary IDs

NIL

4 Source(s) of Funding

Health and Health Services Research Fund

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Hazel Mok

ii Address

Dept. of Medicine and Therapeutics, PWH

iii Phone

2632 3990

iv Email

hazelmok@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Prof. Timothy Kwok

ii Address

Dept. of Medicine and Therapeutics, PWH

iii Phone

2632 3145

iv Email

tkwok@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A randomized trial of chronic disease self management and cognitive training programme to improve diabetic control in older cognitive impaired outpatients

10 Public Title

A randomized trial of chronic disease self management and cognitive training programme to improve diabetic control in older cognitive impaired outpatients

i Public Title in Chinese 研究名稱

以“慢性疾病自我管理與智力訓練課程”改善有智力衰退的老年門診病人的糖尿病控制的隨機硏究

11 Short Title (Optional)

N/A

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?

2012-09-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Diabetic Mellitus

15 Intervention

i Types of intervention

Other

Please specify

Health Services

ii Description/ name of Intervention/article

Chronic disease self-management and cognitive training programme

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Educational programme on chronic disease self-management and cognitive training

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) HbA1C = 7.5-9%, (2) Chinese Memory Symptoms Score >/= 3/5

ii Exclusion Criteria

(1) Higher than secondary education, (2) Short form of geriatric depression scale > 1/4 (3) Dementia, (4) No family caregiver

iii Age Minimum

65

iv Age Maximum

NIL

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-04-01

21 Target Sample Size

154

22 Recruitment Status

Recruiting

23 Primary Outcome

HbA1C

24 Secondary Outcome

Upgrade diabetic medication and neurocognitive test

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-03-31

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13003036

28 Date of Registration in Primary Registry

2013-02-03

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NIL

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Trial History Detail on 2013-07-04