Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00167

2 Trial Registration Date

2008-09-09

i Registration Status

Retrospective

3 Secondary IDs

NIL

4 Source(s) of Funding

N/A

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Lee Chui Ping

ii Address

iii Phone

iv Email

email cplee@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Lee Chui Ping

ii Address

iii Phone

iv Email

email cplee@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

A project on Pharmacist-initiated Diabetic Group Education in a General Outpatient Clinic

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

A project on Pharmacist-initiated Diabetic Group Education in a General Outpatient Clinic

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2006-04-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Diabetes mellitus

15 Intervention

i Types of intervention

Other

Please specify

Pharmacist education

ii Description/ name of Intervention/article

pharmacist providing education on disease, drug and lifestyle modification to the patient in the intervention group

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

3 education sessions of 45 - 60 mins in length for 3 consecutive weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

The control group is usual care

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

Inclusion criteria: have type 2 Diabetes mellitus, attending Wan Tsui Government Clinic GOPC regularly for DM follow-ups, with a baseline HbA1c of 8 or above within the past 6 months, and age between 18 and 75.

ii Exclusion Criteria

Exclusion criteria: with hearing or visual impairment, with language barriers (cannot understand or speak in Cantonese), with active psychiatric disorders or cognitive impairment and with terminal illness.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

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

2006-05-20

21 Target Sample Size

70

22 Recruitment Status

Complete

23 Primary Outcome

HbA1C difference at baseline and after intervention

24 Secondary Outcome

Patient satisfaction and knowledge

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-27

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NIL

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Trial History Detail on 2009-11-19