Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001225606
Ethics application status
Approved
Date submitted
8/11/2014
Date registered
21/11/2014
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Play Activities Program (PAP) for nursing homes residents with chronic pain
Scientific title
A cluster randomized-controlled trial to evaluate the effect of a Play Activities Program (PAP) on pain intensity and interference in nursing homes residents with chronic pain
Secondary ID [1] 285596 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 293438 0
Condition category
Condition code
Alternative and Complementary Medicine 293709 293709 0 0
Other alternative and complementary medicine
Public Health 293710 293710 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the experimental group nursing homes will receive the 8-week Physical Activities Program (PAP). The PAP is a protocol-driven intervention which consists of one session per week for a total of 8 weeks. It is conducted in a group format. Participants are encouraged to sit together in small groups of 5 to 6 for group activities in every session so as to create social bonding.

Each session lasts for 60 minutes. At the beginning of each session, participants will complete 10 minutes of physical exercises including towel dancing; correct body posture and alignment; stretching of arms, legs, and body muscles performed together under the supervision of the research team. Then, different play activities will be carried out each week. They include drawing, making artwork, throwing a parachute together, and other games playing in group.

To ensure the adherence and compliance to protocol, regular meetings will be held among the research team and nursing home staff; also, we shall carefully recruit, thoroughly train, provide ongoing and onsite supervision of research personnel. The nursing home staff training manual, the PAP protocol, the ‘My Play Activities’ portfolio, and materials for play activities of each session has been prepared.
Intervention code [1] 290544 0
Treatment: Other
Intervention code [2] 290545 0
Behaviour
Comparator / control treatment
Participants in the control group nursing homes will gather together once a week for 8 weeks and listen to talks presented by the research team on diseases that are common among older adults and choices of healthful snacks and meals. Each session will last for 40-50 minutes.
Control group
Active

Outcomes
Primary outcome [1] 293518 0
Current pain intensity and pain interference as measured by Brief Pain Inventory (BPI)
Timepoint [1] 293518 0
Baseline and week 8
Secondary outcome [1] 311234 0
Pain self-efficacy as measured by Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [1] 311234 0
Baseline and week 8
Secondary outcome [2] 311235 0
Happiness as measured by Subjective Happiness Scale
Timepoint [2] 311235 0
Baseline and week 8
Secondary outcome [3] 311236 0
Quality of life as measured by SF-12
Timepoint [3] 311236 0
Baseline and week 8

Eligibility
Key inclusion criteria
- aged 65 or above
- able to speak and understand Cantonese
- with an abbreviated mini-mental state examination (MMSE) score >=7
- willing and able to sign a consent form
- have experienced pain during the previous 3 months of intensity score >=3 on the BPI
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- with a current or past history of a psychotic disorder, Alzheimers Disease or Dementia
- with a history of acute stroke or acute myocardial infarction, severe chronic obstructive pulmonary disease, recent fractures, or surgery within the previous 2 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2015
Actual
30/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 6451 0
Hong Kong
State/province [1] 6451 0

Funding & Sponsors
Funding source category [1] 290212 0
Self funded/Unfunded
Name [1] 290212 0
Country [1] 290212 0
Primary sponsor type
Individual
Name
Dr. Mimi Tse
Address
FG425,
Polytechnic University,
Hung Hom,
Kowloon
Country
Hong Kong
Secondary sponsor category [1] 288919 0
Individual
Name [1] 288919 0
Dr NG, Sheung-Mei Shamay
Address [1] 288919 0
ST506,
Polytechnic University,
Hung Hom,
Kowloon
Country [1] 288919 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291919 0
Departmental Research Committee
Ethics committee address [1] 291919 0
Ethics committee country [1] 291919 0
Hong Kong
Date submitted for ethics approval [1] 291919 0
22/03/2013
Approval date [1] 291919 0
15/10/2013
Ethics approval number [1] 291919 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 635 635 0 0
/AnzctrAttachments/366302-884_RO.pdf

Contacts
Principal investigator
Name 48266 0
Dr Mimi Tse
Address 48266 0
FG425,
The Hong Kong Polytechnic University,
Hum Hom,
Kowloon
Country 48266 0
Hong Kong
Phone 48266 0
+85227666541
Fax 48266 0
Email 48266 0
[email protected]
Contact person for public queries
Name 48267 0
Mimi Tse
Address 48267 0
FG425,
The Hong Kong Polytechnic University,
Hum Hom,
Kowloon
Country 48267 0
Hong Kong
Phone 48267 0
+85227666541
Fax 48267 0
Email 48267 0
[email protected]
Contact person for scientific queries
Name 48268 0
Mimi Tse
Address 48268 0
FG425,
The Hong Kong Polytechnic University,
Hum Hom,
Kowloon
Country 48268 0
Hong Kong
Phone 48268 0
+85227666541
Fax 48268 0
Email 48268 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.