Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00143

2 Trial Registration Date

2007-09-18

iRegistration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

Hong Kong College of Family Medicine, Research Fellowship 2007 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

iii Phone

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

iv Email

Tel: 2252 8795

v Affiliation

vi Country

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

i Name

Dr. FUNG, Colman Siu Cheung

ii Address

iii Phone

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

iv Email

Tel: 2252 8789

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 Measuing Programe.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

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

ii Exclusion Criteria

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

2007-09-24

21 Target Sample Size

452

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Blood pressure at 12 +/- 2 week intervals for 4 times in total

24 Secondary Outcome

1. Any incidence of stepping-up or stepping-down of anti-hypertensive medications; 2. Any outcome like admission due to ischaemic heart disease or cerebrovascular disease; 3. Patients¡¦ compliance to hypertension-related lifestyle modification like diet and exercise; 4. Patients¡¦ drug compliance rate 5. Patient¡¦s home blood pressure monitoring compliance rate; 6. Patients¡¦ understanding of hypertension; 7. Patients¡¦ knowledge and usage of home blood pressure monitoring; 8. Satisfaction rate of patients on hypertension management on two groups; 9. Association between the grading of the home blood pressure machines and the blood pressure control outcome. The above information will be collected on each follow-up at the interval of 12 +/- 2 weeks.

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

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 2007-09-18