NCT06168604 Evaluating the Efficacy of the Pain Identification and Communication Toolkit
| NCT ID | NCT06168604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Caregiver Burden |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2023-12-14 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention for caregivers of people with Alzheimer's disease and related dementias (ADRD). PICT provides training in observational pain assessment and coaching in effective pain communication techniques. It will recruit participants from programs of all-inclusive care for the elderly (PACE) and partnering health care clinics. The investigators hypothesize that PICT will help caregivers to recognize and communicate about pain in their care recipients.
Eligibility Criteria
CAREGIVER PARTICIPANTS Inclusion Criteria: 1. Age 21 or older 2. Any gender 3. English speaking 4. Cognitively intact (BOMC ≤10) 5. Provides care to a community-dwelling adult with dementia or cognitive impairment who also has a pain diagnosis 6. Care recipient is not enrolled in hospice 7. Visits the care recipient at least weekly 8. Accessible by telephone Exclusion Criteria: 1. Paid caregiver 2. Age 20 or younger 3. Non-English speaking 4. Cognitively impaired 5. Does not provide care to a person with dementia or cognitive impairment who also has a pain diagnosis 6. Currently enrolled in hospice 7. The patient to whom the caregiver provides assistance is enrolled in hospice 8. Visits care recipient less than weekly 9. Not accessible by telephone. PATIENT PARTICIPANTS Inclusion Criteria: 1. Residing in community settings 2. Record of dementia or cognitive impairment 3. Diagnosis of pain 4. Responsive to environment 5. No terminal illness with life expectancy \<6 months 6. Not in active cancer treatment Exclusion Criteria: 1. Lives in a residential facility (such as a nursing home or assisted living) 2. Enrolled in hospice 3. No dementia or cognitive impairment 4. Unresponsive to environment 5. Has terminal illness with life expectancy \<6 months 6. Are in active cancer treatment
Contact & Investigator
Catherine A Riffin, PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT06168604 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Caregiver Burden. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06168604 currently recruiting?
Yes, NCT06168604 is actively recruiting participants. Contact the research team at lis4019@med.cornell.edu for enrollment information.
Where is the NCT06168604 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06168604 clinical trial?
NCT06168604 is sponsored by Weill Medical College of Cornell University. The principal investigator is Catherine A Riffin, PhD at Weill Medical College of Cornell University. The trial plans to enroll 440 participants.