Clinical trial NCT05056623: Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain
Official title: Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Elderly
Informal Caregivers
Dyadic Intervention
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
name: Shatin Hospital
name: The Hong Kong Polytechnic University
name: The University of Hong Kong
First posted: 2021-09-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: To evaluate the effectiveness of a dyadic pain management program (DPM) in reducing pain and psychological health symptoms, improving pain self-efficacy, quality of life, and physical function in older adults.

Hypothesis: DPM is more effective in reducing pain and psychological health symptoms, improving pain self-efficacy, quality of life, and physical function among older adults than the usual care, upon completion of the DPM (week 8) and over time (week 16).

Design and subjects: Clustered randomized controlled trial with neighborhood elderly centers (NEC) as cluster; 150 dyads (one older adults and his/her caregiver as one dyad) will be recruited from 22 NEC clusters. Each NEC will be randomly allocated to experimental group (receive DPM), control group (receive usual care and pain management pamphlet).

Study instruments: Brief Pain Inventory; Pain Self-Efficacy Questionnaire; Short Form Health Survey-12; Depression, anxiety \& stress; Caregiver Burden Inventory; 6-minute walk test and process evaluation.

Intervention: DPM, each session includes exercise, interactive pain management education, practices on non-drug techniques and using a WhatsApp (WhatsApp Messenger) group to encourage home-based exercise and practice of non-drug methods.

Outcome measures: Pain intensity, pain self-efficacy, perceived health-related quality of life and experience in participating DPM, to be collected at baseline (T0), week 8 (T1), and week 16 (T2).

Data analysis: Multilevel regression and/or Generalized Estimating Equation will be used for within-group and between- group comparisons.

Detailed description: The DPM is an 8-week group-based program. The DPM included 4 weeks of center-based, face-to-face activities and 4 weeks digital-based activities delivered via a WhatsApp group. An 80% participation rate in the face-to-face activities will be regarded as completion of the DPM. Timely make-up sessions will be arranged for those unable to attend the scheduled session.

Eligibility criteria: Older adults / Participants: Inclusion criteria

* Aged 60 or above who are mainly cared for by an informal caregiver and willing to participate the DPM together
* scored \>6 in the Abbreviated Mental Test; a cut-off point of 6 is valid in differentiating between normal and abnormal cognitive functions for geriatric clients29 Can understand Cantonese
* Have a history of non-cancer pain in the past 6 months
* Have a pain score of at least 2 on the Numeric Rating Scale (0-11 numeric scale)
* Able to take part in light exercise and stretching
* One member of the dyad owns a smart phone and can access the Internet

Older adults / Participants: Exclusion criteria

* Have a serious organic disease or malignant tumor
* Have a mental disorder diagnosed by neurologists or psychiatrists
* Will have further medical/surgical treatment in two months
* Experienced drug addiction18

Informal Caregivers : Inclusion criteria

* Aged 18 or above
* As an informal caregiver for the participating older adult
* scored \>6 in the Abbreviated Mental Test; a cut-off point of 6 is valid in differentiating between normal and abnormal cognitive functions for geriatric clients
* Can understand Chinese
* Have a history of non-cancer pain in the past 6 months
* Have a pain score of at least 2 on the Numeric Rating Scale (0-11 numeric scale)
* Able to take part in light exercise and stretching
* Own a smart phone and can assess the internet
* Able to attend the whole sessions in community activity center

Informal Caregivers: Exclusion criteria

* Have serious organic disease or malignant tumor
* Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists
* Have a further medical/surgical treatment in two months or have joined in other pain management program
* Experience a drug addiction problem

Primary outcomes:
measure: Change from baseline pain intensity at week 16
timeFrame: Baseline to week 16
Secondary outcomes:
measure: Pain self-efficacy
timeFrame: Baseline (T0), week 8 (T1), week 16 (T2)
measure: Perceived quality of life
timeFrame: Baseline (T0), week 8 (T1), week 16 (T2)
measure: Psychological health : Depression, anxiety, & stress
timeFrame: Baseline (T0), week 8 (T1), week 16 (T2)
measure: Physical function: 6-minute walk test
timeFrame: Baseline (T0), week 8 (T1), week 16 (T2)
measure: Caregiver Burden Inventory (for the caregivers only)
timeFrame: Baseline (T0), week 8 (T1), week 16 (T2)
measure: Process evaluation
timeFrame: Baseline (T0), week 8 (T1), week 16 (T2)
measure: Field observations
timeFrame: Each DPM will be observed twice within four sessions when carrying out the DPM through 8-week group-based program
measure: Knowledge and skills acquired in managing pain situations for older adults
timeFrame: Baseline (T0), week 8 (T1), week 16 (T2)
measure: Semi-structured interviews for older adults and their caregivers
timeFrame: Individual interviews will be conducted by the Research Assistant 1 within 2 weeks after T1
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Metropolitan University
Study officials:
References: