Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00401

2 Trial Registration Date

2014-03-31

iRegistration Status

Prospective

3 Secondary IDs

CRE-2011.489-T

4 Source(s) of Funding

HMRF

5 Primary Sponsor

CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Vivian Chan

ii Address

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

iii Phone

26095117

iv Email

vivian-chan@cuhk.edu.hk

v Affiliation

Research Assistant

vi Country

Hong Kong

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

i Name

Prof. Benjamin Hon Kei YIP

ii Address

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

iii Phone

2252 8799

iv Email

benyip@cuhk.edu.hk

v Affiliation

Research Assistant Professor

vi Country

Hong Kong

9 Official Scientific Title of the Study

Providing Repeat Prescriptions for Patients with Controlled Hypertension – a randomized controlled trial

10 Public Title

Providing Repeat Prescriptions for Patients with Controlled Hypertension – a randomized controlled trial

i Public Title in Chinese 研究名稱

研究題目: 長期高血壓病患重複處方服務研究

11 Short Title (Optional)

PREP

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-12-08

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE2011-2.489

14 Medical Condition Being Studied

Hypertension

15Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Repeat Prescriptions

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

One year

vi Frequency of the intervention

Same as the control group

16Comparative Treatments

i Description/ name of comparative treatments

Patients in the intervention group will be compared with patients in the usual care group using a single blinded
randomized design. Patients in the control group will during the one-year follow-up have routine check up and see doctors three times (at month 0, 4, 8) and patients in intervention group will see the doctor only once (at month 0). Usual care will resume in both groups at the end of the study(at month 12).

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

Same as the intervention group

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

• Diagnosed with hypertension and no change in medication in the past 12 months.
• Systolic blood pressure below 140 mmHg and diastolic blood pressure above 90 mmHg.
• No past history of cardiovascular complications or diabetes mellitus.
• Annual hypertension check up bloods, urine and retinograph was assessed in the last 12 months and parameters were satisfactory.

ii Exclusion Criteria

• Patient is unable to give consent
• Is concurrently a subject in another clinical trial
• Impaired renal function with an eGFR <60mmol/L
• Past history of myocardial infarction or any cerebrovascular accident within the previous year.
• Patients planning conceive in upcoming year or are pregnant.

iii Age Minimum

18 or above

iv Age Maximum

NA

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

Randomized controlled trial

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-05-05

21 Target Sample Size

414

22 Recruitment Status

Complete

23 Primary Outcome

Systolic and diastolic blood pressure as measured by automated blood measure monitors in the clinic at month 12 or 1 year after subject recruitment.

24 Secondary Outcome

Patient’s level of recommendation of the intervention, as measured by the Net Promoter Score(19), and patient’s acceptability and evaluation of intervention service.

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2015-09-10

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004444

28 Date of Registration in Primary Registry

2014-04-01

Back History

Trial Detail