Evaluating the Efficacy of the Pain Identification and Communication Toolkit

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Change in caregiver-reported pain communication [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in pain management discussions with health care providers [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in concordance between patient and caregiver pain ratings [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in caregiver's ability to recognize pain [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in caregiver's ability to recognize pain behaviors [Срок оценки: Baseline, 1 month, 3 month, 6 month]

Вторичные конечные точки (7)

• Change in patient's behavioral disturbance [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in patient's pain treatments or regimens [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in caregiver burden [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in caregiver distress level [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in caregiver self-efficacy in pain recognition [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in caregiver self-confidence in recognizing pain [Срок оценки: Baseline, 1 month, 3 month, 6 month]
• Change in caregiver self-efficacy in pain-related communication [Срок оценки: Baseline, 1 month, 3 month, 6 month]

Критерии участия

CAREGIVER PARTICIPANTS

Критерии включения

• 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
• Visits the care recipient at least weekly
• Accessible by telephone

Критерии исключения

• 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

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Публикации

• 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. PMID 41345575

Идентификаторы

NCT: NCT06168604 · 22-08025205 · R01AG079932

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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