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Trial record 1 of 1 for:    Developing a Pain Identification and Communication Toolkit (PICT) for Family Caregivers of Persons with Dementia
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Developing a Pain Identification and Communication Toolkit (PICT)

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ClinicalTrials.gov Identifier: NCT03853291
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dementia Chronic Pain Behavioral: PICT Workbook Behavioral: Information Pamphlet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: PICT Workbook
PICT Workbook components will include: 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.
Behavioral: PICT Workbook
The length of PICT and the delivery model will be informed by observational research that has been approved as part of this protocol (the first participant in the observational phase of this work will be enrolled on March 7, 2019). Lacking knowledge from the information gleaned from the observational and field-testing phases of this study we cannot specify with 100% certainty what the intervention will look like. However, it is likely that PICT will consist of 4-5 weekly 30-minute sessions); the expected delivery model will likely include a combination of online (video observation) and telephone coaching.

Active Comparator: Information Pamphlet
Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.
Behavioral: Information Pamphlet
Pamphlet with information about pain and dementia and links to Alzheimer's Association




Primary Outcome Measures :
  1. Feasibility, as measured by the number of sessions completed by participants in the intervention condition [ Time Frame: Post-intervention, 3 months ]
    Feasibility, as measured by the number of sessions completed by participants in the intervention condition

  2. Feasibility, as measured by the number of participants recruited [ Time Frame: Post-intervention, 3 months ]
    Feasibility, as measured by the number of participants recruited

  3. Acceptability, as measured by the number of participants who report that they are "satisfied" or "very satisfied" with the intervention [ Time Frame: Post-intervention, 3 months ]
    Acceptability, as measured by the number of caregivers who report that they are "satisfied" or "very satisfied" with the intervention


Secondary Outcome Measures :
  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 [ Time Frame: Pre- and post-intervention, 3 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853291


Contacts
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Contact: Sylvia Lee, BA 646-962-5884 syl2006@med.cornell.edu
Contact: Patricia Kim, MA 212-746-1758 pak2020@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Catherine Riffin, PhD    781-454-6126    acr2213@med.cornell.edu   
Principal Investigator: Cary Reid         
Principal Investigator: Catherine Riffin         
Principal Investigator: Karl Pillemer         
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Cary Reid, MD/PhD Weill Cornell Medicine
Principal Investigator: Catherine Riffin, PhD Weill Cornell Medicine
Principal Investigator: Karl Pillemer, PhD Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03853291    
Other Study ID Numbers: 1811019718
3P30AG022845-15S1 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Chronic Pain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pain
Neurologic Manifestations