Evaluating a toolkit to help caregivers identify and communicate pain in dementia patients
The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons With ADRD
This study is testing a new toolkit to help caregivers of people with dementia recognize and talk about pain to see if it makes a difference in their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06168604 on ClinicalTrials.gov |
What this trial studies
This study evaluates the Pain Identification and Communication Toolkit (PICT), designed to assist caregivers of individuals with Alzheimer's disease and related dementias (ADRD) in recognizing and communicating about pain. The intervention includes four weekly telephone sessions that provide training in observational pain assessment and effective communication techniques. Participants will be recruited from programs of all-inclusive care for the elderly (PACE) and partnering health care clinics. The study aims to compare the efficacy of PICT against an Attention Control condition and identify factors that may influence its effectiveness.
Who should consider this trial
Good fit: Ideal candidates are family caregivers aged 21 or older who provide care to community-dwelling adults with dementia or cognitive impairment and a pain diagnosis.
Not a fit: Patients who are paid caregivers or those who do not provide care to someone with dementia and pain will not benefit from this study.
Why it matters
Potential benefit: If successful, this toolkit could significantly improve pain management for individuals with dementia, enhancing their quality of life.
How similar studies have performed: Other studies have shown promise in caregiver training interventions for pain management in dementia, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Catherine A Riffin, PhD — Weill Medical College of Cornell University
- Study coordinator: Lisa Sacerio
- Email: lis4019@med.cornell.edu
- Phone: 646-962-6941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.