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Telehealth Pain Self-Management for Employed Adults (E-TIPS)

2022년 7월 25일 업데이트: Dawn Ehde, University of Washington

Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults With Physical Disability: A Randomized Controlled Trial

The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a waitlist control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Chronic pain is one of the most prevalent, disabling, and persistent comorbid conditions associated with physical disabilities, including limb loss, spinal cord injury, traumatic brain injury, and chronic neurodegenerative conditions such as multiple sclerosis. One half to two-thirds of adults with these conditions experience chronic pain. In addition to being associated with disability, depression, sleep disruption, and physical inactivity, chronic pain has deleterious social and societal costs, including job loss and reliance on long-term disability programs.

The E-TIPS intervention aims to address common barriers encountered by employed individuals with chronic pain. People with physical disabilities may be offered face-to-face delivery of pain self-management interventions, in clinical settings during business hours, which limits access to people with physical disabilities who are employed. These individuals must take time off work to attend multiple treatment sessions, overcome transportation difficulties, and contend with the stigma of seeking behavioral healthcare. Telehealth interventions, such as E-TIPS, have considerable potential for expanding the reach of pain self-management interventions for employed people with physical disabilities.

The proposed randomized (1:1), single-blind parallel-group trial will compare the E-TIPS telehealth pain self-management intervention to a waitlist control in adults with physical disabilities and chronic pain who are employed. Outcomes will be assessed before randomization, mid-treatment (6 weeks post-randomization), post-treatment (10 weeks post-randomization; primary endpoint), and 6-month follow up (25 weeks post-randomization). Participants will be recruited from across the US, including at University of Washington (UW) and Shirley Ryan AbilityLab (SRALab).

연구 유형

중재적

등록 (예상)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Carolyn C Green
  • 전화번호: 206-616-9801
  • 이메일: tipsstudy@uw.edu

연구 장소

  • 미국
    • Washington
      • Seattle, Washington, 미국, 98104
        • 모병
        • University of Washington
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 18 years of age or older
  • Self-reported physical disability
  • Chronic pain defined as daily pain of ≥ 3 months duration and ≥ 3 average pain intensity in the past week on a 0-10 numerical rating scale
  • Experiences pain for more than 45 out of the past 90 days (defined as 50% of the time or greater)
  • Reads, speaks, and understands English
  • Has access to and is able to communicate over the telephone with our without assistive devices
  • Is employed, working 15-20 hours per week or more, on average, or earning in excess of substantial gainful activity (approximately $1200/month)

We will enroll individuals with a range of physical disabilities to maximize the generalizability of the results, because there is no evidence that the type of disability affects responsiveness to the proposed treatment

Exclusion Criteria:

  • Under the age of 18
  • Cannot read, speak, or understand English
  • No self-reported physical disability
  • Currently unemployed
  • Plans to retire or leave employment within the study period
  • Working fewer than 15-20 hours per week, on average, and earning less than approximately $1200 per month
  • Cannot communicate or complete assessments over the phone or internet
  • Chronic pain defined as daily pain of ≤ 3 months duration and ≤ 3 average pain intensity in the past week on a 0-10 numerical rating scale
  • Experiences pain for fewer than 45 out of the past 90 days (defined as 50% of the time or less)
  • Currently participating in another pain study or cognitive behavioral therapy (CBT) study

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: E-TIPS
The E-TIPS intervention is based upon a cognitive-behavioral intervention for pain that was developed for and shown to be effective in people with chronic pain and a physical disability such as the conditions of interest in this study. Eight, 45-minute telephone sessions will be delivered by a clinician. A patient workbook will be used to facilitate skill acquisition and rehearsal in and outside of sessions. The intervention includes education about the role of unhelpful thoughts, particularly pain catastrophizing, and unhelpful pain coping behaviors; instruction in how to identify and change unhelpful or negative thinking about pain; utilization of helpful coping strategies; relaxation techniques; behavioral activation including setting goals for physical activation, activity pacing and scheduling; and coping with pain flare-ups. Each session includes a brief relaxation exercise. Participants receive digital audio recordings of relaxation exercises to practice at home.
행동: E-TIPS
Chronic pain self-management strategies for employed individuals with physical disabilities
간섭 없음: Usual care
Participants assigned to the control intervention will continue to pursue standard care (a waitlist). Waitlist control subjects will be offered the opportunity to receive the intervention following completion of the final 6-month follow up outcome assessment.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in pain interference
기간: Baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization
Patient-reported pain interference using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale-6-item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score. Higher scores indicate greater self-reported pain interference.
Baseline (week 0), 12 weeks (post-treatment),and 38 week (6-month follow up) post-randomization

2차 결과 측정

결과 측정
측정값 설명
기간
Change in pain self-efficacy
기간: Baseline (week 0), 10 weeks (post-treatment),and 25 week (6-month follow up) post-randomization
Patient-reported pain self-efficacy for managing pain using the University of Washington Pain Self-Efficacy Scale-6 item. Each item is scored 1 (not at all) to 5 (very much), yielding a raw score between 6 and 30, which is converted to a standard t-score. Higher scores indicate greater patient-reported self-efficacy for managing pain.
Baseline (week 0), 10 weeks (post-treatment),and 25 week (6-month follow up) post-randomization
Change in average pain intensity
기간: Baseline (week 0), 10 weeks (post-treatment),and 25 week (6-month follow up) post-randomization
0-10 Numerical Pain Rating Scale of average pain intensity in past week (0 = no pain, 10 = worst pain imaginable). Higher scores indicate higher levels of self-reported pain intensity.
Baseline (week 0), 10 weeks (post-treatment),and 25 week (6-month follow up) post-randomization

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Washington

협력자

Department of Health and Human Services

수사관

  • 수석 연구원: Dawn M Ehde, PhD, University of Washington

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 3월 2일

기본 완료 (예상)

2023년 3월 31일

연구 완료 (예상)

2023년 9월 1일

연구 등록 날짜

최초 제출

2020년 1월 8일

QC 기준을 충족하는 최초 제출

2020년 1월 28일

처음 게시됨 (실제)

2020년 1월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 7월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 7월 25일

마지막으로 확인됨

2022년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY00005686
  • 7258 (기타 보조금/기금 번호: DHHS)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

All collected IPD will be deposited in a digital data repository. Direct and indirect identifiers will be removed to minimize disclosure risk. The data will be deposited with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR).

IPD 공유 기간

on or or before October 1, 2024

IPD 공유 액세스 기준

Data will be stored in a manner that enables retrieval and use at no cost to users. Each data set will use a Digital Object Identifier (DOI) for future reference and citation. Data submitted to ICPSR, will fit within the scope of the ICPSR Collection Development Policy found at this site: https://www.icpsr.umich.edu/icpsrweb/content/datamanagement/policies/colldev.html.

ICPSR will make the research data from this project available to the broader social science research community. These files, in which direct and indirect identifiers have been removed to minimize disclosure risk, will be accessible directly through the ICPSR Web site. After agreeing to Terms of Use, users with an ICPSR MyData account may download the data at no cost.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

다발성 경화증에 대한 임상 시험

E-TIPS에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Peru

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다