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Trial registered on ANZCTR


Registration number
ACTRN12614000195651
Ethics application status
Approved
Date submitted
15/02/2014
Date registered
24/02/2014
Date last updated
24/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Peer volunteers in a pain management program for older adults
Scientific title
Peer volunteers in an integrative pain management program for frail older adults with chronic pain: study protocol for a single group trial
Secondary ID [1] 284051 0
Nil
Universal Trial Number (UTN)
U1111-1153-1767
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain among frail older adults 291107 0
loneliness level among frail older adults 291109 0
happiness level among frail older adults 291110 0
Condition category
Condition code
Alternative and Complementary Medicine 291451 291451 0 0
Other alternative and complementary medicine
Public Health 291555 291555 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given an 8-week group-based integrated pain management program supplemented with peer volunteers. There will be 16 sessions, with two 1-hour sessions each week.
Session 1 of each week includes:
1) 30 minutes of interactive teaching and sharing - Contents include introduction of pain, impact of pain, drug and non-drug therapy, five sensation therapy (touch, smell, taste, hearing & vision), making a photo album, paper fan, paper flowers and vase, dried flower bags and festival decorations;
2) 20 minutes of exercise - Specific exercises for shoulder and neck, back, arms, whole body and balancing and towel dancing will be taught;
3) 10 minutes of entry and reviewing “I can do it” booklet. The research assistant will lead the sessions and peer volunteers will assist.
Session 2 of each week will only be led by peer volunteers . It includes 30 minutes of revision, 20 minutes of exercise and 10 minutes of entry and reviewing “I can do it” booklet.
Peer volunteers will be provided two training (2 hours each) before the commencement of the voluntary service. They will be informed on the procedure of the program, correct implementation of a variety of exercises and multisensory therapy, communication skills and personal safety. Demonstration of exercise and multisensory therapy will be shown to them. They will also pair up with nursing students and role playing, and to lead a presentation and demonstration in the second workshop.
Intervention code [1] 288744 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291435 0
pain as measured by the numeric rating scale
Timepoint [1] 291435 0
baseline, beginning of each session from week 1-8, 8 and 12 weeks after intervention commencement
Secondary outcome [1] 306763 0
functional mobility as measured by Timed Up and Go Test
Timepoint [1] 306763 0
baseline, 8 and 12 weeks after intervention commencement
Secondary outcome [2] 306764 0
physical activity as measured by the Global Physical Activity Questionnaire
Timepoint [2] 306764 0
baseline, 8 and 12 weeks after intervention commmencement
Secondary outcome [3] 306765 0
use of non-pharmacological methods counted as number of times per week
Timepoint [3] 306765 0
baseline, 8 and 12 weeks after intervention commencement
Secondary outcome [4] 306766 0
Loneliness level as measured by Loneliness Scale
Timepoint [4] 306766 0
baseline, 8 and 12 weeks after intervention commencement
Secondary outcome [5] 306767 0
Happiness level as assessed by the Chinese version of the subjective happiness scale
Timepoint [5] 306767 0
baseline, 8 and 12 weeks after intervention commencement
Secondary outcome [6] 306768 0
Volunteer questionnaire - to assess vollunteers' self-efficacy to learn and implement the IPMP, self-rated pain management knowledge; rating of the training, satisfaction with the program and skills in delivering it, attitudes and prior experiences engaging in voluntary programs for older adults, expectation to the program; perceptions of barriers and facilitators to the program
Timepoint [6] 306768 0
before volunteer training, after volunteer training, 4 and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria for participants:
- aged 60 or above
- scored at least 6 in the Abbreviated Mental Test
- experience pain more than 3 months
- scored at least 1 in the frailty index
- able to hear and understand Cantonese
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- patient with cognitive impairment
- patient with history of mental disorders
- patient with cancer and currently on cancer treatment
- patient suffers from conditions that limit safe participation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5812 0
Hong Kong
State/province [1] 5812 0

Funding & Sponsors
Funding source category [1] 288681 0
University
Name [1] 288681 0
Internal funds, School of Nursing, The Hong Kong Polytechnic University
Country [1] 288681 0
Hong Kong
Primary sponsor type
Individual
Name
Dr. Mimi Mun Yee Tse
Address
FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country
Hong Kong
Secondary sponsor category [1] 287389 0
Individual
Name [1] 287389 0
Dr. Paul Hong Lee
Address [1] 287389 0
PQ433, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country [1] 287389 0
Hong Kong
Secondary sponsor category [2] 287390 0
Individual
Name [2] 287390 0
Dr. Shamay Sheung Mei Ng
Address [2] 287390 0
ST506, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country [2] 287390 0
Hong Kong
Secondary sponsor category [3] 287391 0
Individual
Name [3] 287391 0
Mrs. Bik Kwan Tsien-Wong
Address [3] 287391 0
EF710, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country [3] 287391 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290528 0
Departmental Research Committee, The Hong Kong Polytechnic University
Ethics committee address [1] 290528 0
Ethics committee country [1] 290528 0
Hong Kong
Date submitted for ethics approval [1] 290528 0
Approval date [1] 290528 0
18/02/2014
Ethics approval number [1] 290528 0
HSEARS20140124002

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45978 0
Dr Mun Yee Tse
Address 45978 0
FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country 45978 0
Hong Kong
Phone 45978 0
+852 2766 6541
Fax 45978 0
Email 45978 0
[email protected]
Contact person for public queries
Name 45979 0
Mun Yee Tse
Address 45979 0
FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country 45979 0
Hong Kong
Phone 45979 0
+852 2766 6541
Fax 45979 0
Email 45979 0
[email protected]
Contact person for scientific queries
Name 45980 0
Mun Yee Tse
Address 45980 0
FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
Country 45980 0
Hong Kong
Phone 45980 0
+852 2766 6541
Fax 45980 0
Email 45980 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
SourceTitleYear of PublicationDOI
EmbasePeer volunteers in an integrative pain management program for frail older adults with chronic pain: Study protocol for a randomized controlled trial.2014https://dx.doi.org/10.1186/1745-6215-15-205
N.B. These documents automatically identified may not have been verified by the study sponsor.