Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00545

2 Trial Registration Date

2017-02-02

i Registration Status

Prospective

3 Secondary IDs

2016.687-T

4 Source(s) of Funding

General Research Fund, UGC

5 Primary Sponsor

General Research Fund, UGC

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Dr. Li Wai Chi, Polly

ii Address

Room 410, 4/F, William MW Mong Block, No. 21 Sassoon Road, Pokfulam, Hong Kong

iii Phone

39176686

iv Email

pwcli@hku.hk

v Affiliation

School of Nursing, University of Hong Kong

vi Country

Hong Kong

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

i Name

Dr. Li Wai Chi, Polly

ii Address

Room 410, 4/F, William MW Mong Block, No. 21 Sassoon Road, Pokfulam, Hong Kong

iii Phone

39176686

iv Email

pwcli@hku.hk

v Affiliation

School of Nursing, University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

The effects of a modelling-based narrative intervention on care-seeking behavioural intention and prehospital care-seeking delay in patients with acute myocardial infarction.

10 Public Title

The effects of a modelling-based narrative intervention on care-seeking behavioural intention and prehospital care-seeking delay in patients with acute myocardial infarction.

i Public Title in Chinese 研究名稱

探討及比較兩項不同的心肌梗塞教育計劃能否改善心肌梗塞患者對心肌梗塞的認知及適當的求診行為

11 Short Title (Optional)

Modelling-based narrative intervention to promote timely care-seeking

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?

2017-01-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.687-T

14 Medical Condition Being Studied

Acute myocardial infarction

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

The modelling-based narrative intervention: it will adopt an eclectic approach that integrate behavioral modelling and a narrative approach to promote knowledge and skill internalisation and retention.

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

8 weeks

vi Frequency of the intervention

4 weekly 90 mins session and 1 half day session 4 months later

16 Comparative Treatments

i Description/ name of comparative treatments

A didactic education on AMI care-seeking serve as the control intervention.

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

4 weeks

v Frequency of the comparative treatments

4 weekly sessions

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Age >= 18 years old

Living in the community

A confirmed diagnosis of a prior AMI attack

Consent to participate

ii Exclusion Criteria

Do not understand Cantonese

Impaired communication ability

Psychiatric problems or impaired cognitive functioning (i.e. Abbreviated Mental test <=6)

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Prospective randomized controlled trial

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-03-01

21 Target Sample Size

630

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

The Acute Coronary Syndrome Response Index (ACSRI-C)- Attitude subscale

ii The metric or method of measurement used

To measure attitudes upon symptoms occurrence.

iii The timepoint(s) of primary interest

NA

Primary Outcome

i The Name of the outcome

The Acute Coronary Syndrome Response Index (ACSRI-C)- Belief subscale

ii The metric or method of measurement used

To measure care-seeking beliefs

iii The timepoint(s) of primary interest

NA

24 Secondary Outcome

i The Name of the outcome

The prehospital delay time

ii The metric or method of measurement used

The time interval between onset of acute symptoms and the documented time of arrival at a hospital's emergency department.

iii The timepoint(s) of primary interest

NA

Secondary Outcome

i The Name of the outcome

The use of ambulance

ii The metric or method of measurement used

The primary means of selecting an ambulance as the transportation modality to hospitals

iii The timepoint(s) of primary interest

NA

Secondary Outcome

i The Name of the outcome

The Acute Coronary Syndrome Response Index (ACSRI-C)- Knowledge subscale

ii The metric or method of measurement used

To measure the knowledge of AMI symptoms

iii The timepoint(s) of primary interest

NA

25 Study Information/Publication

i Study Information/Publication Available?

Yes

ii Link to Study Information/Publication

https://academic.oup.com/eurjcn/article/18/3/215/5925206

26 Last Update Date

2022-03-31

27 Primary Registry and Trial Identifying Number

ChiCTR-IIC-17010576

28 Date of Registration in Primary Registry

2017-02-02

Back History

Trial Detail