Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00347

2 Trial Registration Date

2012-12-13

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Kwan, Rick Yiu Cho

ii Address

School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong

iii Phone

2766 6546

iv Email

rick.kwan@polyu.edu.hk

v Affiliation

School of Nursing, The Hong Kong Polytechnic University

vi Country

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

i Name

Lai, Claudia Kam Yuk

ii Address

School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong

iii Phone

2766 6544

iv Email

claudia.lai@polyu.edu.hk

v Affiliation

School of Nursing, The Hong Kong Polytechnic University

vi Country

9 Official Scientific Title of the Study

The effect of acupressure in managing agitation on nursing home resident with dementia

10 Public Title

Acupressure for agitation in dementia

i Public Title in Chinese 研究名稱

穴位按壓對治療老年癡呆症患者煩躁的成效

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-11-13

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Dementia

15 Intervention

i Types of intervention

Other

Please specify

Acupressure

ii Description/ name of Intervention/article

Acupressure, applying manual pressure on subject's acupoints on the body

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Tentatively 4 weeks (will be revised after testing for the ideal duration in the pilot study)

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Comparison group 1: Sham-acupressure, applying manual pressure on the subject's body without acupoints or acupoints without therapeutic effects in theory.

Comparison 2: Usual care, the care provided by the nursing home that it will not be manipulated by the research team.

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) Older people (over 65 years old)
2) Diagnosed and documented to have dementia by a physician (according to DSM-IV-TR)
3) In a state of agitation (according to the criteria set in the instruction manual of Cohen-Mansfield Agitation Inventory)

ii Exclusion Criteria

1) Skin problems on acupoints (eg. skin breakdown, infection)
2) Musculo-skeletal problems (eg. amputation on the acupoints)

iii Age Minimum

65 years old

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

Placebo

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

2013-02-01

21 Target Sample Size

222

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Agitation (will be measured by the Cohen-Mansfield Agitation Inventory), at the following intervals:
T0: Before the commencement of the intervention
T1: Immediately after the intervention
T2: A short delay after the completion of intervention (the delay period is yet to be decided, it will be decided after the pilot study)

24 Secondary Outcome

Stress (will be measured by salivary cortisol level), at the following intervals:
T0: Before the commencement of the intervention
T1: Immediately after the intervention
T2: A short delay after the completion of intervention (the delay period is yet to be decided, it will be decided after the pilot study)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-01-15

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13002977

28 Date of Registration in Primary Registry

2013-01-06

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-04-26