Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00556

2 Trial Registration Date

2017-05-19

i Registration Status

Prospective

3 Secondary IDs

CREC Ref.No. 2016.391-T

4 Source(s) of Funding

self funding

5 Primary Sponsor

Department of Medicine & Therapeutics, Prince of Wales Hospital, Hospital Authority

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Heung Wan CHEUNG

ii Address

Cardiac Care Unit, ward 10C, Prince of Wales Hospital, Shatin

iii Phone

852 55696142

iv Email

chw331@ha.org.hk

v Affiliation

Cardiac Care Unit, ward 10C, Prince of Wales Hospital, Hospital Authority

vi Country

Hong Kong

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

i Name

Yee Man Rebecca WONG

ii Address

Diabetes & Endocrine Centre, ward 3L, Prince of Wales Hospital, Shatin

iii Phone

852-94075291

iv Email

wongymr@ha.org.hk

v Affiliation

Diabetes & Endocrine Centre, Dept. of Medicine and Therapeutics, Prince of Wales Hospital, Hospital Authority

vi Country

Hong Kong

9 Official Scientific Title of the Study

A study to evaluate the effectiveness of a structured patient education on patient discharge in Department of Medicine and Therapeutics, Prince of Wales Hospital

10 Public Title

A study to evaluate the effectiveness of a structured patient education on patient discharge in Department of Medicine and Therapeutics, Prince of Wales Hospital

i Public Title in Chinese 研究名稱

有組織性的病人出院教育的成效研究

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?

2017-03-13

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC Ref.No. 2016.391-T

14 Medical Condition Being Studied

Patients who have the principle diagnose of the following disease of Diabetes mellitus, Stroke, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease and Renal failure

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

It is a randomized control study to evaluate the effectiveness of structured patient education on patient discharge in the department of medicine and therapeutics (M&T). Patients are randomly divided into 3 groups namely usual care group (UC) ; intervention group at discharge (ID) and intervention group at admission (IA). Block randomization is adopted at first, second and third round. After written consent is obtained, patients are invited to answer the self-developed knowledge questionnaire of the specific disease. Patient education is carried out as the usual practice of each ward at UC group. For patients in (ID) and (IA) groups, structured patient education including 1. provide education pamphlets, information sheet of their specific disease. 2. ward nurses adopt a simple discharge reminder to guide patient discharge.
After patient discharge, hospital patient volunteer will telephone patientａt day 3-7 post patient discharge to fill in the self developed knowledge questionnaire on specific disease; Short-form Hong Kong Inpatient Experience Questionnaire: Information on leaving hospital and New Territories East Cluster in-patient satisfaction survey questionnaire.

iii Dosage form of the intervention

nil

iv Dosage of the intervention

nil

v Duration of the intervention

9 months

vi Frequency of the intervention

During patients' hospitalization

16 Comparative Treatments

i Description/ name of comparative treatments

Usual care group (UC) compare with intervention group at discharge (ID) and intervention group at admission (IA)

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

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Patients of the Department of M&T wards，　2. Patients’ main carers if patients cannot communicate，3. Patients who have the principle diagnose of the following disease：Congestive Heart Failure，Chronic Obstructive Pulmonary Disease，Diabetes Mellitus，Renal failure ＆　Stroke。　４。　Aged between 18 and 85 years (inclusive)　５。　Chinese in ethnicity 　　

ii Exclusion Criteria

1. Patients who are unconscious and critically ill。２clinically unstable psychiatric illnesses　３。speak non-Cantonese dialect or different language or had conditions that prevented effective communications eg. Patients who are deaf, mute, have dysphagia or cognitive impairment。４。live in nursing home with supervised treatment

iii Age Minimum

18

iv Age Maximum

85

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Block randomization is adopted at first, second and third round

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

0

Please specify

vi Study Objectives (Optional)

To evaluate the effectiveness of the structured patient education on patient discharge in the wards of Department of Medicine and Therapeutics, Prince of Wales Hospial

20 Anticipated trial start date

2017-05-29

21 Target Sample Size

450

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Changes in patient knowledge of the specific diseases, increase patients' and nurses' satisfaction

ii The metric or method of measurement used

survey

iii The timepoint(s) of primary interest

increase patients' satisifaction and knowledge of their specific diseases

24 Secondary Outcome

i The Name of the outcome

Reduction in re-admission rate

ii The metric or method of measurement used

trace the patients' folders

iii The timepoint(s) of primary interest

reduce re-admission rate,

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-07-03

27 Primary Registry and Trial Identifying Number

ChiCTR-IIC-17011458

28 Date of Registration in Primary Registry

2017-05-19

Back History

Trial Detail