Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00143

2 Trial Registration Date

2007-09-18

iRegistration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Hong Kong College of Family Physicians, Research Fellowship 2007, and Department of Community and Family Medicine, CUHK

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

TAM Wing Yin

ii Address

Department of Community and Family Medicine, 4/F School of Public Health, Prince of Wales Hospital

iii Phone

Tel: 2252 8742

iv Email

v Affiliation

vi Country

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

i Name

Dr. FUNG, Colman Siu Cheung

ii Address

Department of Community and Family Medicine, 4/F School of Public Health, Prince of Wales Hospital

iii Phone

Tel: 2252 8789

iv Email

v Affiliation

vi Country

9 Official Scientific Title of the Study

The effectiveness of a structured home blood pressure monitoring programme at primary care: A cluster randomized controlled trial.

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-08-07

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Hypertension

15Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Structured Home Blood Pressure Measuring Programme.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

36 +/- 2 weeks

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

Nil

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

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

¡´Inclusion criteria: 1. Aged > 40; 2. Mentally capable; 3. Having the diagnosis of hypertension in the CMS record (K86 in ICDC); 4. Having their follow-up of hypertension in the selected clinic; 5. Currently having at least one kind of anti-hypertensive medication; 6. Having their own home blood pressure machines.

ii Exclusion Criteria

¡´ Exclusion criteria: 1. Malignant hypertension « systolic blood pressure >220mmHg or « diastolic blood pressure >120mmHg on day of recruiting; 2. K87 in the ICPC 3. With known secondary hypertension; 4. Having the diagnosis of atrial fibrillation 5. Mental or physical incapacity to monitor blood pressure at home. 6. Do not agree to comply with the instructions, for example, not willing to change from an inappropriate cuff size to an appropriate cuff size 7. Old-aged home residents. 8. With wrist or finger home blood pressure machines.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Historical control

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

2007-10-08

21 Target Sample Size

240

22 Recruitment Status

Unknown

23 Primary Outcome

Blood pressure control

24 Secondary Outcome

(1) Knowledge on proper measurement of their own blood pressure using automated blood pressure machines (2) Attitude of using their automated BP machines (3) Behaviors towards self monitoring of blood pressure (4) Lifestyle related to hypertension (5) Satisfaction level on management of hypertension

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2011-04-18

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-07000705

28 Date of Registration in Primary Registry

2010-05-04

Back History

Trial Detail