NCT06168604 · Weill Medical College of Cornell University
Evaluating the Efficacy of the Pain Identification and Communication Toolkit
(PICT)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Pain Identification and Communication Toolkit
The Pain Identification and Communication Toolkit (PICT) is a multicomponent (6 module) intervention for family caregivers of persons with Alzheimer's disease and related dementias (ADRD). PICT consists of 4 weekly telephone sessions (30-60 minutes each) delivered by a trained interventionist
BEHAVIORAL
Health Promotion Program
The attention control (AC) condition is referred to as the Health Promotion Program (HPP). The HPP will consist of 4 weekly telephone sessions (30-60 minutes each) but focus on caregiver health promotion topics, such as nutrition, exercise, and sleep.
Primary outcome measures
Change in caregiver-reported pain communication
Time frame: Baseline, 1 month, 3 month, 6 month
Change in caregiver-reported pain-related communication as measured by ten questions from the Perceived Involvement in Care Scale (PICS). The range of possible scores is 10-50, where higher scores indicate greater caregiver involvement in patient consultation.
Change in pain management discussions with health care providers
Time frame: Baseline, 1 month, 3 month, 6 month
Change in pain management discussions as measured by the combined number of phone calls and appointments made to discuss pain management recorded in the patient's medical chart.
Change in concordance between patient and caregiver pain ratings
Time frame: Baseline, 1 month, 3 month, 6 month
Change in concordance in patient and caregiver pain ratings as measured by the absolute difference between caregiver and patient pain ratings of the patient's pain on the Iowa Pain Thermometer (IPT). The IPT is scored on a scale of 0-10 where 0 means "no pain" and 10 means "the most intense pain imaginable."
Change in caregiver's ability to recognize pain
Time frame: Baseline, 1 month, 3 month, 6 month
Change in caregiver's ability to recognize pain as measured by the absolute difference between the caregiver-reported PAINAD score and correct PAINAD score (i.e. absolute value of the deviance between the scores). The PAINAD is scored on a scale from 0-10 where 0 means "no pain" and 10 means "severe pain." Participants will be shown multiple videos on which to score the PAINAD.
Change in caregiver's ability to recognize pain behaviors
Time frame: Baseline, 1 month, 3 month, 6 month
Change in caregiver's ability to recognize pain behaviors as measured by the absolute difference between the number of caregiver-reported behaviors within each of the 5 PAINAD behaviors (i.e., Breathing, Negative Vocalization, Facial Expression, Body Language, Consolability) and correct number of behaviors. Participants will be shown multiple videos on which to score the PAINAD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 21 or older
- English speaking
- Cognitively intact (BOMC ≤10)
- Provides care to a community-dwelling adult with dementia or cognitive impairment who also has a pain diagnosis
- Care recipient is not enrolled in hospice
- Visits the care recipient at least weekly
- Accessible by telephone
Exclusion criteria
- Paid caregiver
- Age 20 or younger
- Non-English speaking
- Cognitively impaired
- Does not provide care to a person with dementia or cognitive impairment who also has a pain diagnosis
- Currently enrolled in hospice
- The patient to whom the caregiver provides assistance is enrolled in hospice
- Visits care recipient less than weekly
- Not accessible by telephone. PATIENT PARTICIPANTS Inclusion Criteria:
- Residing in community settings
- Record of dementia or cognitive impairment
- Diagnosis of pain
- Responsive to environment
- No terminal illness with life expectancy \<6 months
- Not in active cancer treatment Exclusion Criteria:
- Lives in a residential facility (such as a nursing home or assisted living)
- Enrolled in hospice
- No dementia or cognitive impairment
- Unresponsive to environment
- Has terminal illness with life expectancy \<6 months
- Are in active cancer treatment
Where
- New York, New York
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2026 · Source of record for eligibility and locations