Clinical trial NCT03823495: Effectiveness of a Peer-led Pain Management Program
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Randomized Controlled Trial
Keywords: pain management
nursing home
elderly
non-drug
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 288
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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). 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. The interventionist is the PV. The one hour session per week will consisted of 20-minute exercise, include correct body posture and alignment, stretching of arms, legs, and body muscles, balancing exercise; shoulder \& neck exercise; knee exercise; towel dancing. While the 30-minute interactive pain management education as well as practices on non-drug management techniques. Topics include: 1) pain situations among older adults; effects of pain in daily life; can we do something? 2) The use of oral drugs for pain: effects and side-effects; 3) The use of non-drug therapy: hot pad \& cold pad; how to use \& safety issues? 4) The use of non-drug therapy: listening to music; 5) the use of non-drug therapy: massage; 6) the use of non-drug therapy: visual stimulation - watching the natural environment \& making a photo album; 7) the use of non-drug therapy: sense of smell \& taste- making a bag of dried flowers \& tasting tea; 8) Revision \& wrapping up. Portfolio entry include the PV will work with the participants to make entry on the activity of the day in the portfolio.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Brief Pain Intensity (questionnaire)
timeFrame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Secondary outcomes:
measure: Pain self-efficacy questionnaire (questionnaire)
timeFrame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
measure: Use of drugs and non-drug methods
timeFrame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
measure: Perceived health-related quality of life
timeFrame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: School of Nursing
state: Kowloon
Study officials:
References:
citation: 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.
citation: Tse 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.