TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS) (TakeCharge)
Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties
The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is hypothesized that if the effects of these conditions are reduced, study participants will demonstrate improved participation in the community and improved employment outcomes. This project is important because the majority of persons with MS experience one or more of the following secondary conditions: fatigue, pain, depression, and cognitive impairment. These secondary conditions are not always readily apparent and constitute what has been described by our Rehabilitation Research and Training Center as "hidden disabilities." Secondary conditions such as pain, depression, fatigue, and cognitive impairment frequently not only cause distress in their own right but also affect employment, participation, and quality of life. Having more than one often compounds the effect; the effect of all may be greater than the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment can worsen depression).
It is critical that this constellation of secondary symptoms be addressed using state of the art techniques based on self-management training and that intervention effects be documented with carefully controlled treatment efficacy studies.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Must be diagnosed with MS by a physician.
- Must be at least 18 years of age.
- Must be able to understand, speak, and read English.
- Must have the presence of at least one of four common secondary conditions (fatigue, pain, depression, cognitive difficulties) that interferes with employment, participation, and functioning.
Exclusion Criteria:
- Unable to understand or read English.
- Severe cognitive impairment, defined as one or more errors on the 6-item screener, that would prevent informed consent and inability to carry on a phone conversation.
- Currently participating in regularly scheduled psychotherapy.
- Psychiatric contraindications such as current psychosis, active suicidal ideation, or current alcohol or drug use.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Self-management Intervention
Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
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Brief counseling technique, self-management,
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활성 비교기: Education
Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
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Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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PHQ 9
기간: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Brief Pain Inventory
기간: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Modified Fatigue Impact Scale
기간: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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2차 결과 측정
결과 측정 |
기간 |
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PROMIS Depression Short Form
기간: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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PROMIS Pain Impact Short Form
기간: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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PROMIS Fatigue Short Form
기간: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dawn Ehde, PhD, University of Washington
- 연구 책임자: George Kraft, MD, University of Washington
간행물 및 유용한 링크
일반 간행물
- Knowles LM, Arewasikporn A, Kratz AL, Turner AP, Alschuler KN, Ehde DM. Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis. Ann Behav Med. 2021 Aug 23;55(9):833-843. doi: 10.1093/abm/kaaa102.
- Ehde DM, Arewasikporn A, Alschuler KN, Hughes AJ, Turner AP. Moderators of Treatment Outcomes After Telehealth Self-Management and Education in Adults With Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1265-1272. doi: 10.1016/j.apmr.2017.12.012. Epub 2018 Jan 11.
- Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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
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