Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain (NCT05373745) | Clinical Trial Compass
CompletedNot Applicable
Managing Pain and Cognitions in Older Adults With Early Cognitive Decline and Chronic Pain
United States267 participantsStarted 2022-06-20
Plain-language summary
The investigators aim to conduct a fully powered randomized controlled trial to compare the efficacy of two symptom management programs for older adults with early cognitive decline (either self-reported or confirmed by testing) and chronic pain, Active Brains 1 and Active Brains 2. The investigators will assess how each program may help in improving multimodal physical, cognitive and emotional function. The investigators will also assess whether improvements in outcomes from the two programs are maintained through 6-months follow-up. The investigators will also explore whether improvements in outcomes are mediated by nonadaptive pain reactions, adaptive coping, social factors and compensatory strategies and modified by demographic and clinical predictors. Both programs will be delivered virtually (Zoom).
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female outpatients, age 60 years or older
* Have nonmalignant chronic pain for more than 3 months
* Reports early cognitive decline (subjective or objective)
* Telephone Interview for Cognitive Status-30 score greater than or equal to 17
* Functional Activities Questionnaire score less than 9
* Able to perform a 6-minute walk test at an accelerated pace
* English fluency/literacy
* Willingness and ability to participate and use an ActiGraph watch and smartphone app to view and sync the step count and sleep data
* Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose
* Cleared by a medical doctor for study participation and no self-reported concerns about physical functioning on the revised Physical Activity Readiness Questionnaire (PAR-Q; score 0)
Exclusion Criteria:
* Diagnosed with dementia or neurodegenerative disease
* Diagnosed with medical illness expected to worsen in the next 6 months
* Diagnosed with serious untreated mental illness (i.e., schizophrenia) or untreated substance use disorder
* Current suicidal ideation reported on self-report
* Engaging in regular mindfulness practice \> 45 min/week or has completed a course of cognitive behavioral therapy in the past 3 months
* Regular use of a digital-monitoring device
* Engagement in regular intensive physical exercis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PROMIS Physical Function
Timeframe: 0 Weeks, 8 Weeks, 6 Months
2
Change in Step Count via the ActiGraph wGT3X-BTLE Accelerometer