Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00554

2 Trial Registration Date

2017-04-27

i Registration Status

Retrospective

3 Secondary IDs

2016/17- CRC - MRG - 05

4 Source(s) of Funding

Princess Margaret Hospital Clinical Research Center Mini Research Grant

5 Primary Sponsor

Princess Margaret Hospital Clinical Research Center

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Wong Yuk Fong

ii Address

PMH Community Nursing Service Center
South Wing, 11th Floor, Nurses' Quarter
232 Lai King Hill Road, Kowloon

iii Phone

64610023

iv Email

wyf811@ha.org.hk

v Affiliation

Princess Margaret Hospital

vi Country

Hong Kong

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

i Name

Wong Yuk Fong

ii Address

PMH Community Nursing Service Center
South Wing, 11th Floor, Nurses' Quarter
232 Lai King Hill Road, Kowloon

iii Phone

66228247

iv Email

bonwon62@gmail.com

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

The effect of community nurse-led transitional care program to enhance patient and health service utilization outcomes for the older adults with high risk hospital readmissions: A randomized Controlled Trial

10 Public Title

The effect of community nurse-led transitional care program to enhance patient and health service utilization outcomes for the older adults with high risk hospital readmissions: A randomized controlled trial

i Public Title in Chinese 研究名稱

社康護士主導之離院後延續家居護理計劃對改善患有慢性疾病的長者健康質素及醫療使用之成效

11 Short Title (Optional)

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?

2017-01-04

iii Full Name of IRB/IEC

Kowloon West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

KW/EX-16-180(105-07)

14 Medical Condition Being Studied

Chronic diseases

15 Intervention

i Types of intervention

Other

Please specify

Nursing interventions

ii Description/ name of Intervention/article

For the intervention group, the community nurse will conduct patient pre-discharge comprehensive assessments within 48 hours after admission.
Discharge plan will be formulated. The community will follow up them at home for 8 weeks with 8 times home visits with 3 times telephone follow up after discharge. Based on individual needs, home care interventions focus on medication management, symptom management, lifestyle modification, medical follow up and psychological support for patients to enhance their self care in disease management and health maintenance. Structural home care intervention protocol will be followed.

iii Dosage form of the intervention

home visit

iv Dosage of the intervention

8 times

v Duration of the intervention

8 weeks

vi Frequency of the intervention

8 times home visits within 8 weeks

16 Comparative Treatments

i Description/ name of comparative treatments

The control group will receive community nursing service as usual with 8 times home visits and without structural home care protocol interventions

ii Dosage form of the comparative treatments

home visit

iii Dosage of the comparative treatments

8 times

iv Duration of the comparative treatments

8 weeks

v Frequency of the comparative treatments

8 times home visits

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1) Aged 65 or older; 2) with current hospitalization through A&E or at risk of frequent hospital readmissions as indicated by Hospital Admission Risk Reduction Program for the Elderly score equal or greater that 0.2

3) have been diagnosis with one or more chronic Obstruction Pulmonary Disease, Diabetes Mellitus, Hypertension, Congestive Heart Failure

4) Chinese and able to communicate with Cantonese

5) cognitively intact as indicated by Abbreviated Mental Test score ( Hong Kong version) of 6 or more out of 10

6) living within the hospital service area and discharge to home

7) willing to accept community nursing service

ii Exclusion Criteria

Paticipants who are discharged to institutionalized care or followed by a designated disease -specific management program

being under care by Hospital Authority Integrated Care Model Program, Virtual Ward Program or non-governmental organization enhanced home care program, will be excluded

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

Randomized Control Trial

ii Nature of control

Dose comparison

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-05-02

21 Target Sample Size

142

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

Primary outcome

ii The metric or method of measurement used

the number of hospitalization, emergency room visits and length of hospital stay

iii The timepoint(s) of primary interest

T0 ( at discharge), T1 ( 4 weeks after discharge), T2 ( 8 weeks after discharge and when the program is completed), T3 ( 12 weeks after discharge)

24 Secondary Outcome

i The Name of the outcome

Secondary outcome

ii The metric or method of measurement used

psychological status by using the Hospital Anxiety and Depression Scale, quality of lifeby using the Chinese version of the EuroQoL - 5 D Questionnaire, self-efficacy by using the Chinese version of the Short form Chronic Disease self-efficacy Scale and satisfaction of care questionnaire

iii The timepoint(s) of primary interest

T0( at discharge), T2 ( 8 weeks after discharge and when the program completed )

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-02-18

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-05-26