Effectiveness of a Peer-led Pain Management Program

Randomized Controlled Trial Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03823495
• Other study ID #: PLPMP
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: The Hong Kong Polytechnic University
• Contact: Mimi Mun Yee Tse, PhD
• Phone: 2766 6541
• Email: mimi.tse[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Randomized Controlled Trial

Intervention

Other:
• 12-week PAP
It is a non-drug intervention, using exercises to reduce elderlies chronic pain.

Locations

Country	Name	City	State
Hong Kong	School of Nursing	Hung Hom	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain self-efficacy questionnaire (questionnaire)	Pain self-efficacy questionnaire is a 7-point likert scale ranging from 0 to 6. It will be used to assess the participants' confidence in their ability to perform specific tasks or their confidence in performing more generalized constructs such as coping with chronic non-malignant pain.	Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Secondary	Use of drugs and non-drug methods	The drugs that are used, and their frequency of use will be collected from medication charts	Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Secondary	Perceived health-related quality of life	The chinese version of the SF-12 questionnaire is a likert scale to assess participants perceived physical and mental health-related quality of life.	Change from baseline to 12-week (after the intervention) and 24-week (follow up)