Effectiveness of a Peer-led Pain Management Program

NCT ID: NCT03823495

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-03

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

12-week PAP

Intervention Type OTHER

It is a non-drug intervention, using exercises to reduce elderlies chronic pain.

Control group

The control group will receive the usual care and a pain management pamphlet distributed by nursing home staff

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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12-week PAP

It is a non-drug intervention, using exercises to reduce elderlies chronic pain.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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TSE Mun Yee Mimi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Nursing

Hung Hom, Kowloon, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Mimi Mun Yee Tse, PhD

Role: CONTACT

2766 6541 ext. 6541

Kai Chun Johnson Law, MSc

Role: CONTACT

2766 7880 ext. 7880

References

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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.

Reference Type DERIVED
PMID: 34544469 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34422864 (View on PubMed)

Other Identifiers

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PLPMP

Identifier Type: -

Identifier Source: org_study_id

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