Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00512

2 Trial Registration Date

2016-05-09

i Registration Status

Prospective

3 Secondary IDs

CREC 2016.204

4 Source(s) of Funding

Hong Kong Jockey Club Charities Trust

5 Primary Sponsor

Professor Samuel Yeung-shan WONG

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Wing Yin TAM

ii Address

Room 04, 4/F, Lek Yuen Health Centre,
9 Lek Yuen Street,
Shatin

iii Phone

25039053

iv Email

wingyintam@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Samuel Yeung-shan WONG

ii Address

4/F, School of Public Health, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

iii Phone

2252-8774

iv Email

yeungshanwong@cuhk.edu.hk

v Affiliation

Division of Family Medicine and Primary Health Care, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

The Efficacy of Complex Integrated Community Primary Care Programme in People with Complex Chronic Conditions

10 Public Title

The Community Primary Care Programme: Enhancing care of people with complex chronic conditions

i Public Title in Chinese 研究名稱

促進多重長期疾病患者的護理研究計劃

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?

2016-04-28

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.204

14 Medical Condition Being Studied

With 2 or more long term chronic diseases

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

For those who are eligible for the case clinic, they will be seen by a case management professional (a social worker/nurse) and a management plan will be made and the medical and psycho-social needs will be addressed with input from the multidisciplinary team members including the participating NGOs. For all patients enrolled, baseline assessments and subsequent outcome and process evaluations of health related indicators will be measured by the project coordinator regularly to monitor the quality and progress of the programme. For these patients, a complex integrated primary care programme with three components will be provided: 1) Family members/carers resilience and support programme including a) support group interventions e.g. connecting existing network and resources and online group discussion and webpage modules; b) professional education interventions such as behavioral management, self enhancement skills and chronic disease education; 2) Patients empowerment programme including a) self-management programme b) transformative learning and c) socialization to build up partnership between individuals and illness, family, carers and health professionals and 3) Direct Intervention on family members or patients: counseling/therapy intervention targeted on specific treatment needs and home visits to help patients with specific health or social needs. Assessment and progress monitoring will be carried on month 0 and month 24.

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

2 years

vi Frequency of the intervention

1-8 week

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

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) Chinese

2) Age 60 or above

3) With 2 or more long term chronic diseases

4) Patient from the public and private primary care clinics with complex psychological and social needs (i.e. immigrants, single mothers, elderly who lives alone with multiple health problems etc.)

5) Service user from community non-government organizations (NGO) in the region with more than one chronic medical condition

ii Exclusion Criteria

1) Cognitive impairment with MMSE score less than 18

2) Immobility. Confined to a bed or chair for > 22 hours per day; for at least 4 of the past 7days.

3) Lacking capacity of consent.

iii Age Minimum

60

iv Age Maximum

100+

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-05-23

21 Target Sample Size

1000

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

The change of EQ5D5L from baseline to the end of month 24

ii The metric or method of measurement used

EQ5D5L questionnaire

iii The timepoint(s) of primary interest

Month 0 and month 24.

24 Secondary Outcome

i The Name of the outcome

Change of lifestyle (e.g. physical activities level, smoking, alcohol consumption)

ii The metric or method of measurement used

Physical activities level will be assessed by International Physical Activity Questionnaire. Smoking and alcohol consumption habit will be recorded by history taking and AUDIT-C questionnaire.

iii The timepoint(s) of primary interest

Month 0 and month 24.

Secondary Outcome

i The Name of the outcome

Change of health parameters (eg, blood pressure, pain assessment and body mass index (BMI),

ii The metric or method of measurement used

Blood pressure data will be collected by blood pressure monitor, pain assessment will be done by Brief Pain Inventory, Body mass index will be calculated by the formula: Body weight/(Body Height x Body Height)

iii The timepoint(s) of primary interest

Month 0 and month 24.

Secondary Outcome

i The Name of the outcome

Change of health service utilization pattern (having a family doctor, self-care, use of public primary care clinics (ie, the general outpatient clinic (GOPC)) and accident and emergency service)

ii The metric or method of measurement used

Change of health service utilization pattern will be recorded by history taking

iii The timepoint(s) of primary interest

Month 0 and month 24.

Secondary Outcome

i The Name of the outcome

Change of psychosoical health (e.g. anxiety, depression, social support, loneliness level and meaningfulness in life),

ii The metric or method of measurement used

Anxiety level will be assessed by GAD-7 questionnaire, Depression level will be assessed by PHQ-9, social support can be measured by MSPSS questionnaire, loneliness level can be measured by 6-item De Jong Gierveld Loneliness Scale and meaningfulness of life will be assessed by the C-MLQ.

iii The timepoint(s) of primary interest

Month 0 and month 24.

Secondary Outcome

i The Name of the outcome

Change of self care ability, cognitive assessment and habit of seeking health information

ii The metric or method of measurement used

Self care ability will be assessed by IADL questionnaire, cognitive assessment will be done by MMSE questionnaire and habit of seeking health information will be done by eHEALS questionnaire and a social media utilization questionnaire

iii The timepoint(s) of primary interest

Month 0 and month 24.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-07-24

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-05-09