Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00367

2 Trial Registration Date

2013-05-09

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

N/A

5 Primary Sponsor

Seeking sponsor from RGC GRF / ECS

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Justina Liu

ii Address

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

iii Phone

27664097

iv Email

justina.liu@polyu.edu.hk

v Affiliation

The Hong Kong Polytechnic University

vi Country

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

i Name

Justina Liu

ii Address

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

iii Phone

27664097

iv Email

justina.liu@polyu.edu.hk

v Affiliation

The Hong Kong Polytechnic University

vi Country

9 Official Scientific Title of the Study

Implementation of observational pain management protocol to improve pain management for long-term institutionalized older care residents with dementia: study protocol for a cluster-randomized controlled trial

10 Public Title

Implementation of observational pain management protocol to improve pain management for long-term institutionalized older care residents with dementia: study protocol for a cluster-randomized controlled trial

i Public Title in Chinese 研究名稱

隨機進行利用“疼痛行為觀察評估及管理草案”
改善癡呆症患者的疼痛管理

11 Short Title (Optional)

Evaluate the Effectiveness of Observational Pain Management Protocol for nursing home residents with dementia.

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?

2013-04-16

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

No

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Observational Pain Management Protocol for nursing home elderly residents with dementia

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

The control groups will continue their usual pain management strategies for nursing home elderly residents with dementia

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

Participants must be > 65 years, of either gender. They must have been living in the long-term care home for > 6 months. Their general health must be stable (with no acute physiological or psychiatric illnesses, and no history of fractures or emergency hospital admissions within the past 3 months.) Participants must be officially diagnosed with some form of dementia. Their cognitive state will be assessed by the Cantonese-Mini Mental State Examination (C-MMSE). The participants must have at least one pain-related diagnosis such as osteoarthritis, low back pain, or rheumatoid arthritis. Each participant’s communication ability will be assessed by the communication score based on two items in the interRAI-Home Care (HC) Assessment (formerly called the Minimum Data Set-HC): (1) making self understood and (2) ability to understand others. These two items are rated on a 5-point scale: 0 = understood, 1 = usually understood, 2 = often understood, 3 = sometimes understood, 4 = rarely or never understood. A total communication score is summed from these two items and ranges from 0 to 8, in which 0 means no communication problems and 8 means very severe communication impairment. Participants must have a communication score > 5 to be eligible to be recruited into this study.

ii Exclusion Criteria

To avoid altered behaviour patterns caused by other acute diseases, the participants must not have been suffering from any acute physiological / psychiatric illnesses during the period of data collection. Residents who are experiencing distressing social circumstances that may affect their daily behavioural pattern will be excluded from this study.

iii Age Minimum

65

iv Age Maximum

99

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Dose comparison

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-01-02

21 Target Sample Size

122

22 Recruitment Status

Recruiting

23 Primary Outcome

use of pharmacological and non-pharmacological pain treatments for 12 weeks of the protocol implementation

24 Secondary Outcome

observational pain score for 12 weeks of the protocol implementation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-03-25

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13003206

28 Date of Registration in Primary Registry

2013-05-09

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-02-21