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Caregiver BurdenPICTNCT06168604

Evaluating the Efficacy of the Pain Identification and Communication Toolkit

A study testing Pain Identification and Communication Toolkit and Health Promotion Program in people with Caregiver Burden and Cognitive Impairment, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Caregiver Burden, Cognitive Impairment, Dementia
What is being tested?
Pain Identification and Communication Toolkit and Health Promotion Program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
440 participants
Where
1 siteUnited States
Study dates
14 Dec 2023to 30 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 21 or older
  • Any gender
  • 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
Show all 14Show fewer
  • Visits the care recipient at least weekly
  • Accessible by telephone
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • The patient to whom the caregiver provides assistance is enrolled in hospice
  • Visits care recipient less than weekly
  • Not accessible by telephone.
  • PATIENT PARTICIPANTS
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa Sacerio contact

646-962-6941

lis4019@med.cornell.edu

United States1 site, 1 recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Lisa Sacerio, 646-962-6941, lis4019@med.cornell.edu

    Recruiting

Other trials in United States

About this study

Official title: The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons With ADRD

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.

Read the detailed description

Up to 60% of older persons with Alzheimer's disease and related dementias (ADRD) suffer from bothersome pain and nearly half experience pain-related activity limitations. Despite best-practice guidelines calling for routine pain assessment of persons with ADRD, pain is severely under-detected and poorly managed in this population. A major barrier to the identification and treatment of pain in persons with ADRD is impaired communication. Informal (family) caregivers are well situated to detect pain and facilitate management in persons with ADRD, given their extensive involvement in care activities. However, caregivers receive virtually no guidance or training in these areas. The Pain Identification and Communication Toolkit (PICT) is a multicomponent intervention for ADRD caregivers that provides training in observational pain assessment and coaching in effective pain communication techniques. PICT consists of 4 weekly telephone sessions (30-60 minutes each) delivered by a trained interventionist. This project aims to (1) determine the efficacy of PICT compared with an Attention Control (AC) condition, (2) identify the patient and caregiver factors that may moderate the effects of PICT on study outcomes, and (3) evaluate the mechanisms (theoretically-derived variables) by which PICT affects study outcomes. Participants will be recruited from programs of all-inclusive care for the elderly (PACE) programs and partnering health care clinics. They will complete assessments at 0 (baseline), 1, 3, and 6 months.

Being tested
Pain Identification and Communication Toolkit, Health Promotion Program
Keywords
Family Caregivers, Informal Caregivers, Dementia, Pain
Medical subject headings
Caregiver Burden, Cognitive Dysfunction, Dementia, Alzheimer Disease, Chronic Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Identification and Communication ToolkitBehavioural

    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

  • Health Promotion ProgramBehavioural

    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.

Study groups in NCT06168604
Study groupRoleWhat they receive
Pain Identification and Communication ToolkitExperimentalThe Pain Identification and Communication Toolkit (PICT) components include: a) training using an observational assessment tool to detect pain in persons with Alzheimer's disease and related dementias (ADRD), b) coaching and feedback by a trained interventionist in effective strategies for communicating with providers about pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set through routine practice and homework exercises. A trained interventionist will deliver the PICT intervention following a manualized protocol to the caregiver participants. Patient participants will not receive any intervention.
Receives: Behavioral: Pain Identification and Communication Toolkit
Attention ControlSham comparatorThe Attention Control (AC) condition, also known as the Health Promotion Program (HPP), focuses on caregiver health promotion topics, such as nutrition, exercise, and sleep. A trained interventionist will provide education on these topics using scripted material, use active listening and open questioning techniques, and provide the HPP participants with worksheets (e.g., meal plans) to complete between sessions to mirror the homework activities in the PICT condition for the caregiver participants. Patient participants will not receive any intervention.
Receives: Behavioral: Health Promotion Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in caregiver-reported pain communication

    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.

    Measured: Baseline, 1 month, 3 month, 6 month

  2. Change in pain management discussions with health care providers

    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.

    Measured: Baseline, 1 month, 3 month, 6 month

  3. Change in concordance between patient and caregiver pain ratings

    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."

    Measured: Baseline, 1 month, 3 month, 6 month

  4. Change in caregiver's ability to recognize pain

    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.

    Measured: Baseline, 1 month, 3 month, 6 month

  5. Change in caregiver's ability to recognize pain behaviors

    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.

    Measured: Baseline, 1 month, 3 month, 6 month

Secondary outcomes (7)

  1. Change in patient's behavioral disturbance

    Change in patient's behavioral disturbance as measured by 11 items on the Memory and Behavior Problem Checklist. Questions are asked on a likert scale of 0-never occurs to 4-occurs daily or more often for a total possible score of 44, with higher scores indicating more behavioral disturbance in the patient.

    Measured: Baseline, 1 month, 3 month, 6 month

  2. Change in patient's pain treatments or regimens

    Change in number of each type of caregiver-reported patient treatment/regimens.

    Measured: Baseline, 1 month, 3 month, 6 month

  3. Change in caregiver burden

    Change in caregiver burden will be assessed by the 7-item version of the Zarit Burden Index (ZBI). Response options for each item range from 0-"never" to 4-"nearly always". The highest possible score is 28 and the lowest possible score is 0; higher scores indicate more caregiver burden.

    Measured: Baseline, 1 month, 3 month, 6 month

  4. Change in caregiver distress level

    Change in caregiver distress as measured by 11 items on the Memory and Behavior Problem Checklist. Questions are asked on a likert scale of 0-not at all to 4-extremely for a highest possible score of 44 and a lowest possible score of 0, with higher scores indicating more caregiver distress.

    Measured: Baseline, 1 month, 3 month, 6 month

  5. Change in caregiver self-efficacy in pain recognition

    Change in caregiver self-efficacy in pain recognition as measured by 9 items adapted from The Health Education Impact Questionnaire on a scale of 1-"completely disagree" to 5-"completely agree" with a highest total score of 45 and a lowest total score of 9. Higher total scores indicate higher self-efficacy in pain recognition.

    Measured: Baseline, 1 month, 3 month, 6 month

  6. Change in caregiver self-confidence in recognizing pain

    Change in self-confidence in recognizing pain as measured by four items adapted from McCabe et al., 2012. Questions are asked on a scale of 1-"not at all confident" to 4-"very confident," with a highest possible score of 16 and a lowest possible score of 4. Higher scores indicate more confidence in ones ability to recognize pain.

    Measured: Baseline, 1 month, 3 month, 6 month

  7. Change in caregiver self-efficacy in pain-related communication

    Change in caregiver self-efficacy in pain-related communication as measured by a modified 10-item version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI) Scale. Questions are asked on a scale of 1 - "not at all confident" to 5 - "very confident" with a highest total score of 50 and a lowest total score of 10. Higher scores indicate higher self-efficacy in pain-related communication between a caregiver and a healthcare provider.

    Measured: Baseline, 1 month, 3 month, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2023
  2. Study start14 Dec 2023
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06168604
Sponsor's protocol ID
22-08025205
Other IDs
R01AG079932
Acronym
PICT
Status last verified
Feb 2026
First submitted
1 Dec 2023
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: At the conclusion of the study, a complete, cleaned, de-identified copy of the quantitative data components described above (i.e., data from questionnaires and medical chart review) will be incorporated into a computerized, shareable database. This database, along with data dictionaries and data collection forms, will be made available to share with interested external investigators upon completion of the study and by the online publication date of the primary and secondary aims in a peer-reviewed journal.

Publications

  • Turner SG, Brody L, Mei L, Figueroa-Nieves A, Smiley A, Reid MC, Herr K, Sacerio L, Moxley J, Pillemer K, Riffin C. The pain identification and communication toolkit: a training program to support family caregivers of persons with ADRD. BMC Geriatr. 2025 Dec 4;26(1):31. doi: 10.1186/s12877-025-06717-8.

    PubMed 41345575

Questions about this trial

What is this clinical trial studying?

A study testing Pain Identification and Communication Toolkit and Health Promotion Program in people with Caregiver Burden and Cognitive Impairment, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa Sacerio (646-962-6941, lis4019@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in caregiver-reported pain communication (time frame: Baseline, 1 month, 3 month, 6 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06168604, which also lists 1 linked publication.

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 12 Feb 2026.

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