Effectiveness of a Peer-led Pain Management Program
1 other identifier
interventional
288
1 country
1
Brief Summary
Objective: To evaluate the efficacy of a peer-led pain management program (PAP) in improving pain self-efficacy, reduce pain, enhancing use of drugs and non-drug methods and quality of life among nursing home residents Hypothesis: PAP lead by peer volunteer (PV) is more effective than receive usual care and pain management pamphlet, in reducing pain intensity, enhancing pain self-efficacy, use of drugs and non-drug methods, health-related quality of life upon completion of the PAP (week 12) and over time (week 24). Design and subjects: Clustered randomized controlled trial with nursing homes as cluster; 288 residents will be recruited from 12 nursing homes. Each nursing home will be randomly allocated to experimental group (PV led PAP), control group (receive usual care and pain management pamphlet). Study instruments: Brief Pain Inventory, Pain Self-Efficacy Questionnaire, Use of drugs and non-drug methods log book, Short Form Health Survey-12 and process evaluation. Intervention: 12-week PAP (one 1-hour session per week). Outcome measures: Pain intensity, pain self-efficacy, use of non-drug pain relief methods, perceived health-related quality of life and experience in participating PAP, to be collected at baseline (T0), week 12 (T1), and week 24 (T2). Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for within-group and between- group comparisons. Expected results: Significant reduction in pain and enhancement in pain-related parameters, making peers support models in elderly care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2018
CompletedFirst Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 12, 2020
February 1, 2020
3.5 years
September 12, 2018
February 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Pain Intensity (questionnaire)
Brief Pain Inventory is a 10 point likert scale ranging from 0 to 10. It will be used to assess the multidimensional nature of the participants' pain, including its intensity and subsequent interference with life activities
Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Secondary Outcomes (3)
Pain self-efficacy questionnaire (questionnaire)
Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Use of drugs and non-drug methods
Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Perceived health-related quality of life
Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Study Arms (2)
Experimental group
EXPERIMENTAL12-week PAP (one 1-hour session per week). Each session includes 20-minute exercise, 30-minute interactive pain management education, practices on non-drug management techniques, and portfolio entry for activities of the day.
Control group
NO INTERVENTIONThe control group will receive the usual care and a pain management pamphlet distributed by nursing home staff
Interventions
It is a non-drug intervention, using exercises to reduce elderlies chronic pain.
Eligibility Criteria
You may qualify if:
- scored ≥ 6 in the Abbreviated Mental Test Chinese Version
- scored ≥ 4 in the Brief Pain Inventory Chinese Version
- scored ≥ 60 in the Modified Barthel Index Chinese Version
- able to speak and understand Cantonese
You may not qualify if:
- scored ≥ 8 in the Geriatric Depression Scale Chinese Version
- history of psychotic disorders
- currently undergoing cancer treatment
- has conditions that limit safe participation in exercising
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Nursing
Hung Hom, Kowloon, Hong Kong
Related Publications (2)
Tse MMY, Tang SK, Ng S, Li Y, Cheung DSK, Kwan RYC. Assessing the fidelity of a peer-led chronic pain management program (PAP). Trials. 2021 Sep 20;22(1):644. doi: 10.1186/s13063-021-05599-6.
PMID: 34544469DERIVEDTse MMY, Ng SSM, Lee PH, Bai X, Lo R, Tang SK, Chan KL, Li Y. Effectiveness of a Peer-Led Pain Management Program in Relieving Chronic Pain and Enhancing Pain Self-Efficacy Among Older Adults: A Clustered Randomized Controlled Trial. Front Med (Lausanne). 2021 Aug 5;8:709141. doi: 10.3389/fmed.2021.709141. eCollection 2021.
PMID: 34422864DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 12, 2018
First Posted
January 30, 2019
Study Start
June 3, 2018
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
February 12, 2020
Record last verified: 2020-02