Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00567

2 Trial Registration Date

2017-10-13

i Registration Status

Prospective

3 Secondary IDs

16151222

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

Food and Health Bureau

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Chunqing ZHANG

ii Address

DLB 644, David C. Lam Building, Hong Kong Baptist University Shaw Campus, No. 55 Renfrew Road, Kowloon Tong, Kowloon, Hong Kong

iii Phone

+3411 6404

iv Email

cqzhang@hkbu.edu.hk

v Affiliation

Department of Physical Education, Hong Kong Baptist University

vi Country

Hong Kong, China

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

i Name

Chunqing ZHANG

ii Address

DLB 644, David C. Lam Building, Hong Kong Baptist University Shaw Campus, No. 55 Renfrew Road, Kowloon Tong, Kowloon, Hong Kong

iii Phone

+3411 6404

iv Email

cqzhang@hkbu.edu.hk

v Affiliation

Department of Physical Education, Hong Kong Baptist University

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

Promoting influenza prevention for elderly people in Hong Kong: A Health Action Process Approach

10 Public Title

Promoting influenza prevention for elderly people in Hong Kong: A Health Action Process Approach

i Public Title in Chinese 研究名稱

促進香港長者感冒預防：健康行為過程理論

11 Short Title (Optional)

Promoting influenza prevention for elderly people

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-01-11

iii Full Name of IRB/IEC

Other

Please specify

The Committee on the Use of Human & Animal Subjects in Teaching and Research (HASC), HKBU

iv IRB/IEC approval reference number

14150541

14 Medical Condition Being Studied

None

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Both motivational and volitional components of the Health Action Process Approach(HAPA)-based Intervention

iii Dosage form of the intervention

Face-to-face and telephone-delivered intervention

iv Dosage of the intervention

A one-off group education sessions along with 3-month weekly telephone-delivered intervention sessions + another one-off group session and another 3-month weekly telephone-delivered intervention sessions

v Duration of the intervention

1-2 hours group education + 15-20minutes telephone-delivered intervention

vi Frequency of the intervention

Weekly

16 Comparative Treatments

i Description/ name of comparative treatments

Only motivational component of the Health Action Process Approach(HAPA)-based Intervention

ii Dosage form of the comparative treatments

Face-to-face and telephone-delivered intervention

iii Dosage of the comparative treatments

A one-off group education sessions along with 3-month weekly telephone-delivered intervention sessions

iv Duration of the comparative treatments

1-2 hours group education + 15-20minutes telephone-delivered intervention

v Frequency of the comparative treatments

Weekly

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

65 years or over

Report never or rarely adopting any of the influenza prevention behaviours listed by the research group.

Non-vaccinated within one year

ii Exclusion Criteria

Older adults who are dementia

Older adults who are fragile to move

iii Age Minimum

65

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Participants will be randomized into either two intervention groups or control group

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

1

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-11-30

21 Target Sample Size

261

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Influenza preventive behaviours

ii The metric or method of measurement used

Self-report questionnaire

iii The timepoint(s) of primary interest

Baseline, the 3-month, 6-month, and 12-month follow-up occasions.

24 Secondary Outcome

i The Name of the outcome

HAPA psychological variables

ii The metric or method of measurement used

Self-report questionnaire

iii The timepoint(s) of primary interest

Baseline, the 3-month, 6-month, and 12-month follow-up occasions.

25 Study Information/Publication

i Study Information/Publication Available?

Yes

ii Link to Study Information/Publication

https://rfs2.fhb.gov.hk/app/fundedsearch/projectdetail.xhtml?id=2222

26 Last Update Date

2018-11-07

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-17012981

28 Date of Registration in Primary Registry

2017-10-13

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Trial History Detail on 2018-11-07