Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00604

2 Trial Registration Date

2018-05-02

i Registration Status

Prospective

3 Secondary IDs

CRE 2017.380

4 Source(s) of Funding

Tung Wah Group of Hospitals

5 Primary Sponsor

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

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Doris, Sau-fung Yu

ii Address

Rm 729, 7/F, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories

iii Phone

852-39434289

iv Email

dyu@cuhk.edu.hk

v Affiliation

The Nethersole School of Nurisng, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Doris, Sau-fung Yu

ii Address

Rm 729, 7/F, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories

iii Phone

852-39434289

iv Email

dyu@cuhk.edu.hk

v Affiliation

The Nethersole School of Nurisng, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

The effects of strengths-based dyadic program on health-related quality of life (HRQL) of people with mild cognitive impairment and mild dementia in the community

10 Public Title

The effects of strengths-based dyadic program on health-related quality of life (HRQL) of people with mild cognitive impairment and mild dementia in the community

i Public Title in Chinese 研究名稱

探討中度認知障礙及中度腦退化症患者及其照顧者參與優勢取向計劃後在改善與健康相關之生活質素的成效之研究

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?

2017-08-17

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.380

14 Medical Condition Being Studied

Mild cognitive impairment

Mild dementia

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Strengths-based dyadic program. The educative-counseling program will contain five interactive educative-counseling sessions, with four sessions focus on the following the core topics for the dyads, followed by one wrap up session. The four core topics include:
a) effective dyadic communication,
b) managing memory loss and the associated problems,
c) ways to stay active even with cognitive impairment or caregiving responsibilities;
d) recognizing and managing maladaptive emotions and behaviors in coping with the disease or caregiving.

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

9 weeks

vi Frequency of the intervention

1 hour per session, 1 session per week

16 Comparative Treatments

i Description/ name of comparative treatments

The control intervention will include the usual care as provided by the Neighborhood Elderly Centre (NEC) or District Elderly Community Centre (DECC) under the operation of the Tung Wah Hospital.

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

People with a confirmed diagnosis of MCI as indicated by a Clinical Dementia Rating Score of 0.5 or mild dementia and their primary co-residing family caregivers

Able to communicate with the intervention specialist and research assistants

No pre-existing acute psychotic disease

Consent to participate

ii Exclusion Criteria

Subjects with psychotic disorders, unable to communicate and unable to give consent will be excluded.

iii Age Minimum

60

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Prospective single-blind randomized controlled trial

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-05-02

21 Target Sample Size

142 dyads

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Cognitive Function

ii The metric or method of measurement used

30-item Mini-Mental State Examination Questionnaire