Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00340

2 Trial Registration Date

2012-09-27

i Registration Status

Prospective

3 Secondary IDs

NA

4 Source(s) of Funding

NA

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

Cheng Pak Wing 鄭柏榮

ii Address

Department of Psychiatry, G/F, Multi-Centre, Tai Po Hospital, Tai Po, N.T., Hong Kong

iii Phone

85251457901

iv Email

Calvincheng1983@gmail.com

v Affiliation

Department of Psychiatry, the Chinese University of Hong Kong

vi Country

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

i Name

Linda CW Lam 林翠華

ii Address

Department of Psychiatry, G/F, Multi-Centre, Tai Po Hospital, Tai Po, N.T., Hong Kong

iii Phone

85226076040

iv Email

cwlam@cuhk.edu.hk

v Affiliation

Department of Psychiatry, the Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

An exploratory study on the effects of Integrated Attention training for healthy older Chinese adults with subjective cognitive complaints but no clinical dementia

10 Public Title

A study on the effects of Integrated Attention training for healthy older chinese adults

i Public Title in Chinese 研究名稱

綜合注意力訓練對有主觀認知投訴而非認知障礙的健康長者之效用的實驗性研究

11 Short Title (Optional)

Nil

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?

2012-06-11

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

mild cognitive impairment

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

This will be a single blind Randomized Controlled Trial of 6 months duration. Older Chinese adults /9aged 60 or above) with subjective cognitive complaints without dementia will be randomized into 2 intervention groups. The intervention groups comprised of Integrated Attention Training Group(A) and Psycoeducation Group (C). Each participant will participate in regular activities arranged by the participating elderly centres for first 3 months and practices at home for next 3 months.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Six months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Description of treatments
1. The integrated attention (A) training group will have training on different attention tasks. Basic elements will include practice of focused attention on internal cues, selective attention, divided attention and everyday functional tasks focus on attention.
2. The controlled (C) group will be received psychoeducation on different health related topics.
Intervention schedule
The intervention will be conducted in two phases. 1. Induction phase – There will be a total of 12 training (once weekly) sessions over a 12 week period. Each training session will last for 45 minutes including introduction and closing. 2. Intervention phase - After the induction course has been completed, subjects will be advised to practice the respective training for not less than 30 minutes per day, and not less than 3 days per week. A practice manual will be offered to participants to aid home practice. To booster adherence to program, the intervention instructors will provide a refresher lesson every month. A log book will be used to keep track of the adherence. Research staffs will phone up participants every two weeks to remind continuation of program.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Subjects aged 60 or above.
2. Subjective cognitive complaints, measured by abbreviated Memory Inventory for the Chinese

ii Exclusion Criteria

1. Clinical diagnosis of dementia, according to DSM-Ⅳ
2. Had a chronic psychiatric illness or an acute episode of major depression
3. Taking a psychotropic or other medication known to affect cognition (e.g. benzodiazepines, anti-dementia medication, etc.)
4) Clinically depressed, assessed by the Hamilton Depression Rating Scale
5) Attending regular cognitive training or other intervention for brain health during the study period
6) History of major neurological deficit including history of stroke, transient ischemic attack or traumatic brain injury
7) Significant communicative impairments

iii Age Minimum

60 years

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-11-01

21 Target Sample Size

200

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Clinical Dementia Rating (CDR) sum of boxes scores. The CDR is a semi-structured clinical interview for the severity of cognitive impairment rated along six dimensions of cognition and function. CDR indicates global cognition reflecting changes in overall function from very early stages of cognitive decline

24 Secondary Outcome

1) Cognitive assessment included digit span, visual span, category verbal fluency (CVFT), trail making tests, mini mental state examination (MMSE), Alzheimer’s Disease Assessment Scale- Cognitive (ADAS-Cog) and Attention Network Test (ANT)
2) Subjective cognitive assessment (SCC) measured by Memory Inventory for the Chinese (MIC). It is a 22 item questionnaire exploring subjective cognitive problems in everyday activities.

3) Depressive and anxiety symptomatology was assessed with the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale

4) Everyday function would be assessed by the Disability Assessment for Dementia(DAD), the validated Chinese version assesses both basic and instrumental activities of daily living along three dimensions (initiation, organization and effectiveness). Earlier studies conducted in Hong Kong suggested that the initiation and organization aspects of IADL may be affected in Chinese elders with MCI

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-10-15

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2012-09-27