Evaluating the Efficacy of the Pain Identification and Communication Toolkit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 21 or older
Any gender
English speaking
Cognitively intact (BOMC ≤10)
Disqualifiers
Paid caregiver
Age 20 or younger
Non-English speaking
Cognitively impaired
Trial design
Design model
Parallel
Treatments tested in this trial
Pain Identification and Communication Toolkit
BehavioralThe 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 Program
BehavioralThe 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.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: Pain Identification and Communication ToolkitExperimental treatment 1 intervention
Group B: Attention ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, 1 month, 3 month, 6 month2
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.
Time frame
Baseline, 1 month, 3 month, 6 month3
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."
Time frame
Baseline, 1 month, 3 month, 6 month4
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.
Time frame
Baseline, 1 month, 3 month, 6 monthSecondary outcomes
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.
Time frame
Baseline, 1 month, 3 month, 6 month2
Change in patient's pain treatments or regimens
Change in number of each type of caregiver-reported patient treatment/regimens.
Time frame
Baseline, 1 month, 3 month, 6 month3
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.
Time frame
Baseline, 1 month, 3 month, 6 month4
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.
Time frame
Baseline, 1 month, 3 month, 6 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov