Chronic PainNCT05056623
Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain
A study testing Dyadic pain management program in people with Chronic Pain and Elderly, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Elderly, Informal Caregivers
- What is being tested?
- Dyadic pain management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Jul 2022to 1 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain: a Cluster Randomized Controlled Trial
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).
Read more
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.
Read the 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.
- Conditions
- Chronic Pain, Elderly, Informal Caregivers, Dyadic Intervention
- Being tested
- Dyadic pain management program, Usual care and pain management pamphlet
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic pain management programBehavioural
Face-to-face part: The DPM will start with 20-30 minutes of physical exercise supervised by research assistant, followed by 20-minutes of pain management education. Communication skills regarding the practice of various pain management techniques by the participants and their caregivers will be taught. At the end of the session, the caregiver and research assistant will help the older adults to make portfolio entries on the activities of the day, to help them recall the various pain-relief methods learned in each class.
Home-based part: An exercise book will be given to guide them in performing exercises at home. It is recommended to perform 30 minutes of exercise, 3 times a week, at home and the more frequent the exercise time, the better.
All participants will join a WhatsApp group to receive teaching materials and videos of the physical exercises learned, for practice at home. The team will produce compact disc (CD) with the exercise video clips to the dyads for revision.
Usual care and pain management pamphletOther
Usual care and pain management pamphlet
| Study group | Role | What they receive |
|---|---|---|
| Dyadic pain management program | Experimental | 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. Receives: Behavioral: Dyadic pain management program |
| Usual care and pain management pamphlet | Other | The participants in the control group will receive the usual care and a pain management pamphlet. Receives: Other: Usual care and pain management pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain intensity at week 16
The Chinese version of the Brief Pain Inventory will be used to assess the multidimensional nature of pain, including intensity and interference with life activities in the previous 24 hours. Minimum score = 0; Maximum score = 10. Higher scores mean a worse outcome.
Measured: Baseline to week 16
Secondary outcomes (9)
Pain self-efficacy
A Chinese version of the Pain Self-Efficacy Questionnaire (PSEQ) will be used to measure self-efficacy in coping with activities despite pain. Minimum score = 0; Maximum score = 60. Higher scores mean a better outcome.
Measured: Baseline (T0), week 8 (T1), week 16 (T2)
Perceived quality of life
The Chinese version of the EuroQoL 5-dimension 5-level version (EQ-5D-5L) will be used to measure quality of life of participants as well as the cost effectiveness of the proposed dyadic pain management program. It is a health-related quality of life measure developed by the EuroQol Group. Minimum score = 0; Maximum score = 100. Higher scores means a better outcome.
Measured: Baseline (T0), week 8 (T1), week 16 (T2)
Psychological health : Depression, anxiety, & stress
The Depression Anxiety Stress Scales 21-items (DASS-21) is a self-administered psychological instrument to evaluate degrees of depression, anxiety, and stress. Minimum score. Minimum score = 0; Maximum score: Depression = 28+, Anxiety = 20+, Stress = 37+. Higher score means a worse outcome.
Measured: Baseline (T0), week 8 (T1), week 16 (T2)
Physical function: 6-minute walk test
A 6-minute walk test to test exercise tolerance in chronic disease.
Measured: Baseline (T0), week 8 (T1), week 16 (T2)
Caregiver Burden Inventory (for the caregivers only)
The Caregiver Burden Inventory comprises 24 items measuring five dimensions of burden related to the caregiving role. Minimum score = 0; Maximum score 96. Higher score means a worse outcome.
Measured: Baseline (T0), week 8 (T1), week 16 (T2)
Process evaluation
A process evaluation will be carried out to identify the strengths and limitations of the intervention from the perspectives of the older adults and their caregivers
Measured: Baseline (T0), week 8 (T1), week 16 (T2)
Field observations
To monitor the quality of the implementation of the DPM. A total of 48 observations will be conducted by the principal investigator, guided by a fidelity checklist. 9 The checklist indicates the implementation of DPM in terms of four levels: low/not observed; observed to a small degree; observed to a medium degree, and high implementation.
Measured: Each DPM will be observed twice within four sessions when carrying out the DPM through 8-week group-based program
Knowledge and skills acquired in managing pain situations for older adults
A questionnaire will be given to the participants in the experimental and control groups regarding their knowledge and skills in managing pain situations. Minimum score = 0, Maximum score = 10. Higher score means a better outcome.
Measured: Baseline (T0), week 8 (T1), week 16 (T2)
Semi-structured interviews for older adults and their caregivers
To obtain the widest range of opinions and comments from different perspectives, equal proportions of participants 1) with significant positive changes between the baseline and first post-test measurements, 2) without significant changes, and 3) with negative changes, will be invited for interviews. They will be asked to comment on their experiences and feelings about the intervention that they received and on changes in their behavior, their perceptions of the intervention, their beliefs, concerns, and views of the difficulties of managing pain; and how the intervention could be improved to meet their needs.
Measured: Individual interviews will be conducted by the Research Assistant 1 within 2 weeks after T1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start14 Jul 2022
- Primary completion1 Sep 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund, Shatin Hospital, The Hong Kong Polytechnic University, The University of Hong Kong
- Responsible party
- Principal investigator, Professor Mimi TSE Mun Yee, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056623
- Sponsor's protocol ID
- DPM
- Status last verified
- Oct 2024
- First submitted
- 24 Mar 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Dyadic Pain Management Program for Community-dwelling Older Adults with Chronic Pain: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05056623
- Acronym / sponsor ID
- DPM
- Conditions
- Chronic Pain, Elderly, Informal Caregivers, Dyadic Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund, Shatin Hospital, The Hong Kong Polytechnic University, The University of Hong Kong
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Sep 2021 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyadic pain management program | Experimental | Behavioral: Dyadic pain management programThe 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. |
| Usual care and pain management pamphlet | Other | Other: Usual care and pain management pamphletThe participants in the control group will receive the usual care and a pain management pamphlet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Dyadic pain management programFace-to-face part: The DPM will start with 20-30 minutes of physical exercise supervised by research assistant, followed by 20-minutes of pain management education. Communication skills regarding the practice of various pain management techniques by the participants and their caregivers will be taught. At the end of the session, the caregiver and research assistant will help the older adults to make portfolio entries on the activities of the day, to help them recall the various pain-relief methods learned in each class. Home-based part: An exercise book will be given to guide them in performing exercises at home. It is recommended to perform 30 minutes of exercise, 3 times a week, at home and the more frequent the exercise time, the better. All participants will join a WhatsApp group to receive teaching materials and videos of the physical exercises learned, for practice at home. The team will produce compact disc (CD) with the exercise video clips to the dyads for revision. | Behavioural | Dyadic pain management program |
| Usual care and pain management pamphletUsual care and pain management pamphlet | Other | Usual care and pain management pamphlet |
Primary outcome
Change from baseline pain intensity at week 16
Time frame: Baseline to week 16
The Chinese version of the Brief Pain Inventory will be used to assess the multidimensional nature of pain, including intensity and interference with life activities in the previous 24 hours. Minimum score = 0; Maximum score = 10. Higher scores mean a worse outcome.
9 secondary outcomes
Pain self-efficacy
Time frame: Baseline (T0), week 8 (T1), week 16 (T2)
Perceived quality of life
Time frame: Baseline (T0), week 8 (T1), week 16 (T2)
Psychological health : Depression, anxiety, & stress
Time frame: Baseline (T0), week 8 (T1), week 16 (T2)
Physical function: 6-minute walk test
Time frame: Baseline (T0), week 8 (T1), week 16 (T2)
Caregiver Burden Inventory (for the caregivers only)
Time frame: Baseline (T0), week 8 (T1), week 16 (T2)
Process evaluation
Time frame: Baseline (T0), week 8 (T1), week 16 (T2)
Field observations
Time frame: Each DPM will be observed twice within four sessions when carrying out the DPM through 8-week group-based program
Knowledge and skills acquired in managing pain situations for older adults
Time frame: Baseline (T0), week 8 (T1), week 16 (T2)
Semi-structured interviews for older adults and their caregivers
Time frame: Individual interviews will be conducted by the Research Assistant 1 within 2 weeks after T1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
RecruitingPhase 3
Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
Recruiting
Light Bulb Stimuli to Reduce Chronic Pain
Fibromyalgia, Musculoskeletal Pain
Active, not recruiting
Probiotics for Inflammation in Pediatric Chronic Pain
Chronic Pain, Body Mass Index >=85th Percentile
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic pain management program in people with Chronic Pain and Elderly, run by Hong Kong Metropolitan 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?
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 8 Oct 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain intensity at week 16 (time frame: Baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.