DementiaPICTNCT03853291

Developing a Pain Identification and Communication Toolkit

A study testing PICT Workbook and Information Pamphlet in people with Dementia and Chronic Pain, run by Weill Medical College of Cornell University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 to 100 years
Conditions the study is for: Dementia, Chronic Pain
What is being tested?: PICT Workbook and Information Pamphlet
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 siteUnited States
Study dates: 8 Mar 2019to 11 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Family caregiver
Age 21 or older
English speaking
Cognitively intact
Provides at least 8 hours of care per week to a person with dementia and pain
Has provided care for at least 6 months

Who cannot join

Paid caregiver
Age 20 or younger
Non-English speaking
Cognitively impaired
Does not provide at least 8 hours of care per week to a person with dementia who also has a pain diagnosis
Has not provided care for at least 6 months

Show all 13Show fewer

Currently enrolled in hospice
The patient to whom the caregiver provides assistance is in enrolled in hospice
Care recipient does not have dementia diagnosis or pain diagnosis
For field test and interview phases:
Healthcare professionals:
Currently providing clinical services to persons with dementia and/or chronic pain
Has provided these clinical services for at least 1 year

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medicine
New York, New York, 10065

Other trials in United States

About this study

Official title: Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia

The proposed research will develop, refine, and pilot test the Pain Identification and Communication Toolkit (PICT), an intervention to help family caregivers of community-dwelling persons with dementia identify pain symptoms and communicate those symptoms to health care providers. Informed by self-efficacy theory, PICT will include: a) training in administering an observational assessment tool to identify pain in persons with dementia, b) coaching in effective communication about the person with dementia's pain symptoms, c) future planning for steps to take when pain is detected, and d) updating caregivers' skills through routine practice with the pain assessment tool. All components will be vetted and iteratively field-tested with a sample of racially and ethnically diverse caregivers of community-dwelling persons with dementia and health care providers. A two-group pilot randomized trial will examine the acceptability, feasibility, and preliminary impact of PICT on caregivers' initiation of pain-related communication with health care providers.

Conditions: Dementia, Chronic Pain
Being tested: PICT Workbook, Information Pamphlet
Medical subject headings: Dementia, Chronic Pain

What participants receive

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

PICT WorkbookBehavioural
PICT Workbook: The PICT workbook is a 31-page manual, which includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set. Participants in the intervention condition also attended four weekly 30-minute sessions with an interventionist through a combination of online (video observation) and telephone coaching to go over the Workbook.
Information PamphletBehavioural
Pamphlet with information about pain and dementia and links to Alzheimer's Association

Study groups in NCT03853291
Study group	Role	What they receive
PICT Workbook	Experimental	PICT Workbook components includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's 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. Receives: Behavioral: PICT Workbook
Information Pamphlet	Active comparator	Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website. Receives: Behavioral: Information Pamphlet
Family Caregivers - Interview Phase	No intervention	Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
Healthcare Providers - Interview Phase	No intervention	Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
Family Caregivers - Field Test Phase	No intervention	Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
Healthcare Providers - Field Test Phase	No intervention	Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.

What is being measured

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

Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Measured: Post-intervention, 3 months
Feasibility, as Measured by the Number of Participants Recruited
Measured: Baseline
Acceptability, as Measured by the Number of Participants Who Report That the Intervention Was "Very Effective" or "Moderately Effective" in Helping Them Feel More Confident in Their Ability to Communicate Pain to Healthcare Providers
Measured: Post-intervention, 3 months

Secondary outcomes (1)

Caregiver Initiated Pain-related Communication, as Measured by the Number of Caregivers Who Report Making Contact With Any of the Care Recipients' Health Care Providers to Discuss Pain-related Concerns
Measured: Baseline, Post-intervention-3 months

Timeline

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

8 Mar 201911 Aug 2021

First posted25 Feb 2019
Study start8 Mar 2019
Primary completion11 Aug 2021
Study completion11 Aug 2021

Why it stopped: terminated due to Covid and end of funding period for key personnel

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DementiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03853291
Sponsor's protocol ID: 1811019718
Other IDs: 3P30AG022845-15S1
Acronym: PICT
Status last verified: Jun 2022
First submitted: 22 Feb 2019
Last updated: 7 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Riffin C, Brody L, Mukhi P, Herr K, Pillemer K, Rogers M, Henderson CR Jr, Reid MC. Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. Innov Aging. 2023 Jul 13;7(10):igad074. doi: 10.1093/geroni/igad074. eCollection 2023.
PubMed 38094933

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
ClinicalTrials.gov ID: NCT03853291
Acronym / sponsor ID: PICT / 1811019718
Conditions: Dementia, Chronic Pain
Study type: Interventional
Recruitment status: TerminatedReason stopped: terminated due to Covid and end of funding period for key personnel
Enrolment: 85 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), Cornell University, Rutgers University, University of Iowa
Study start: 8 Mar 2019 (actual)
Primary completion: 11 Aug 2021 (actual)
Study completion: 11 Aug 2021 (actual)
First posted: 25 Feb 2019 (actual)
Results: Posted 7 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
PICT Workbook	Experimental	Behavioral: PICT WorkbookPICT Workbook components includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's 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.
Information Pamphlet	Active comparator	Behavioral: Information PamphletInformational pamphlet about pain in dementia and a link to the Alzheimer's Association website.
Family Caregivers - Interview Phase	No intervention	–Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
Healthcare Providers - Interview Phase	No intervention	–Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone. The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
Family Caregivers - Field Test Phase	No intervention	–Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
Healthcare Providers - Field Test Phase	No intervention	–Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers. After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance. They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives. Health care providers will answer a similar set of questions. Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.

Who may qualify

Ages: 21 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Family caregiver
Age 21 or older
English speaking
Cognitively intact
Provides at least 8 hours of care per week to a person with dementia and pain

Key exclusion criteria (13 listed)

Paid caregiver
Age 20 or younger
Non-English speaking
Cognitively impaired
Does not provide at least 8 hours of care per week to a person with dementia who also has a pain diagnosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PICT WorkbookPICT Workbook: The PICT workbook is a 31-page manual, which includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set. Participants in the intervention condition also attended four weekly 30-minute sessions with an interventionist through a combination of online (video observation) and telephone coaching to go over the Workbook.	Behavioural	PICT Workbook
Information PamphletPamphlet with information about pain and dementia and links to Alzheimer's Association	Behavioural	Information Pamphlet

Primary outcome

Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Time frame: Post-intervention, 3 months
Feasibility, as Measured by the Number of Participants Recruited
Time frame: Baseline
Acceptability, as Measured by the Number of Participants Who Report That the Intervention Was "Very Effective" or "Moderately Effective" in Helping Them Feel More Confident in Their Ability to Communicate Pain to Healthcare Providers
Time frame: Post-intervention, 3 months

1 secondary outcome

Caregiver Initiated Pain-related Communication, as Measured by the Number of Caregivers Who Report Making Contact With Any of the Care Recipients' Health Care Providers to Discuss Pain-related Concerns
Time frame: Baseline, Post-intervention-3 months

Results and safety

Results posted to the registry on 7 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PICT Workbook	18	16
Information Pamphlet	16	13
Family Caregivers - Interview Phase	18	18
Healthcare Providers - Interview Phase	16	16
Family Caregivers - Field Test Phase	6	6
Healthcare Providers - Field Test Phase	11	11

Primary outcome: Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions

Time frame: Post-intervention, 3 months. Count of participants. Unit: Participants

Measure	PICT Workbook n = 16
Value	16

Population analysed: 2 participants did not complete the intervention, n=1 lost to follow-up, n=1 determined ineligible post-enrollment. Data were not collected from participants in the interview and field test arms/phases.

Primary outcome: Feasibility, as Measured by the Number of Participants Recruited

Time frame: Baseline. Count of participants. Unit: Participants

Measure	PICT Workbook n = 18	Information Pamphlet n = 16
Value	18	16

Population analysed: Data were not collected from participants in the interview and field test arms/phases.

Primary outcome: Acceptability, as Measured by the Number of Participants Who Report That the Intervention Was "Very Effective" or "Moderately Effective" in Helping Them Feel More Confident in Their Ability to Communicate Pain to Healthcare Providers

Time frame: Post-intervention, 3 months. Count of participants. Unit: Participants

Measure	PICT Workbook n = 16
Value	13

Population analysed: For the intervention condition: 2 participants did not complete the intervention, n=1 lost to follow-up, n=1 determined ineligible post-enrollment. Data from the information pamphlet arm was not collected. Data were not collected from participants in the interview and field test arms/phases.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PICT	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Control Group	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Family Caregivers - Interview Phase	0 of 0	0 of 0	0
Healthcare Providers - Interview Phase	0 of 0	0 of 0	0
Family Caregivers - Field Test Phase	0 of 0	0 of 0	0
Healthcare Providers - Field Test Phase	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): This is a pilot RCT focused on feasibility and acceptability, and was not fully powered to evaluate the intervention's efficacy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38094933Riffin C, Brody L, Mukhi P, Herr K, Pillemer K, Rogers M, Henderson CR Jr, Reid MC. Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. Innov Aging. 2023 Jul 13;7(10):igad074. doi: 10.1093/geroni/igad074. eCollection 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cary Reid, MD/PhD principal investigator

Weill Medical College of Cornell University

Catherine Riffin, PhD principal investigator

Weill Medical College of Cornell University

Karl Pillemer, PhD principal investigator

Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PICT Workbook and Information Pamphlet in people with Dementia and Chronic Pain, 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 7 Jun 2022. 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. 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?

Yes. Results are posted in the registry (first posted 7 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions (time frame: Post-intervention, 3 months). The study lists 3 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 NCT03853291, 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 7 Jun 2022.