Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00528

2 Trial Registration Date

2016-09-13

i Registration Status

Prospective

3 Secondary IDs

NA

4 Source(s) of Funding

NA

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

HO SUK KWAN

ii Address

RmA, 9th Floor, Block 5, Handsome Court, Tuen Mun, N.T. Hong Kong

iii Phone

91233251

iv Email

vho99999@yahoo.com.hk

v Affiliation

NA

vi Country

Hong Kong

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

i Name

SUK KWAN HO

ii Address

RmA, 9th Floor, Block 5, Handsome Court, Tuen Mun, N.T. Hong Kong

iii Phone

91233251

iv Email

vho99999@yahoo.com.hk

v Affiliation

Department of Medicine (Nursing), The Chinese University of Hong Kong. Caritas Medical Centre

vi Country

Hong Kong

9 Official Scientific Title of the Study

The effectiveness of educational intervention on glaucoma patients for improving their topical medication adherence and outcomes: a randomized controlled trial

10 Public Title

The effectiveness of educational intervention on glaucoma patients for improving their topical medication adherence and outcomes: a randomized controlled trial

i Public Title in Chinese 研究名稱

增強青光眼病人遵循處方使用眼藥水教育方法成效的隨機對照研究

11 Short Title (Optional)

NA

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?

2015-09-02

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC Rrf. No:2015.383-T

14 Medical Condition Being Studied

Primary Open Angle Glaucoma

15 Intervention

i Types of intervention

Other

Please specify

Education

ii Description/ name of Intervention/article

Educational intervention

iii Dosage form of the intervention

Small class teaching with video, and demonstration and return demonstration, 5 reminder call

iv Dosage of the intervention

1

v Duration of the intervention

Around 1 hour for education session. 10-15 Minutes for each reminder call

vi Frequency of the intervention

once

16 Comparative Treatments

i Description/ name of comparative treatments

Usual care

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adult primary open angle glaucoma patients in Ophthalmic Clinic in Caritas Medical Centre

ii Exclusion Criteria

dependent patients, language barrier and patients who cannot give consent for study

iii Age Minimum

18 years old

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Block randomisation

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

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-09-27

21 Target Sample Size

128 to168 depends on power and fleasibility

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Improve adherence

ii The metric or method of measurement used

self report adherence record

iii The timepoint(s) of primary interest

around 4 months

24 Secondary Outcome

i The Name of the outcome

improve self instillation eye drop skills and knowledge of glaucoma and eye drops, Anxiety and depression. qulaity of life. Intraocular pressure

ii The metric or method of measurement used

questionnaires and check list of observed skills, HADS, glaucoma quality of life , data in medical record

iii The timepoint(s) of primary interest

around 4 montths

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-09-14

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-09-13