Randomized Controlled TrialNCT03823495
Effectiveness of a Peer-led Pain Management Program
A study testing 12-week PAP in people with Randomized Controlled Trial, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Randomized Controlled Trial
- What is being tested?
- 12-week PAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Jun 2018to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
Read the 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.
- Conditions
- Randomized Controlled Trial
- Being tested
- 12-week PAP
- Keywords
- pain management, nursing home, elderly, non-drug
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week PAPOther
It is a non-drug intervention, using exercises to reduce elderlies chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: 12-week PAP |
| Control group | No intervention | The control group will receive the usual care and a pain management pamphlet distributed by nursing home staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Secondary outcomes (3)
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.
Measured: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Use of drugs and non-drug methods
The drugs that are used, and their frequency of use will be collected from medication charts
Measured: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
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.
Measured: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start3 Jun 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Randomized Controlled TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSE Mun Yee Mimi, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823495
- Sponsor's protocol ID
- PLPMP
- Status last verified
- Feb 2020
- First submitted
- 12 Sep 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34544469Tse 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.
PubMed 34422864
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03823495
- Acronym / sponsor ID
- PLPMP
- Conditions
- Randomized Controlled Trial
- Keywords
- pain management, nursing home, elderly, non-drug
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 3 Jun 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: 12-week PAP12-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 intervention | –The control group will receive the usual care and a pain management pamphlet distributed by nursing home staff |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week PAPIt is a non-drug intervention, using exercises to reduce elderlies chronic pain. | Other | Experimental group |
Primary outcome
Brief Pain Intensity (questionnaire)
Time frame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
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
3 secondary outcomes
Pain self-efficacy questionnaire (questionnaire)
Time frame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Use of drugs and non-drug methods
Time frame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Perceived health-related quality of life
Time frame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 34544469Tse 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.
- Derived from this study: PubMed 34422864Tse 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week PAP in people with Randomized Controlled Trial, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mimi Mun Yee Tse, PhD (2766 6541 ext. 6541, mimi.tse@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Intensity (questionnaire) (time frame: Change from baseline to 12-week (after the intervention) and 24-week (follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823495, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.