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
NCT number | NCT03823495 |
Other study ID # | PLPMP |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 3, 2018 |
Est. completion date | December 2021 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | School of Nursing | Hung Hom | Kowloon |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
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) |
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