- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00118547
Health Behavior Change in Chronic Disease Management
연구 개요
상세 설명
There is increasing recognition that coordinated approaches to disease management improve medication adherence. Intervention in chronic illness may be viewed as a multidisciplinary and collaborative process based upon behavioral principles, including the idea that illness management skills are learned and behavior is self-directed, motivation and self-efficacy can affect self care, monitoring and responding to changes in physical and mental health improves adaptation to illness, and the health care system can support or hinder self care. Preliminary findings suggest that telemedicine home monitoring providing cues to medication administration, brief evaluation of potential barriers (e.g., fatigue, cognition, side effects), identification of areas for future education (e.g., additional injection training), and an opportunity for feedback to providers (e.g., side effects) are well tolerated and may improve self monitoring of chronic medical conditions.
The proposed study is a six-month, two group parallel-design, controlled trial to evaluate feasibility and obtain effect size estimates for a behavioral intervention to improve adherence to MS disease modifying therapy (DMT) using telemedicine home monitoring. Monitoring will include brief weekly text-based prompting to complete a series of approximately 10-15 questions regarding factors that are expected to affect adherence to DMT. Areas of assessment will include the development of side effects (e.g., flu-like symptoms), disease specific symptoms (e.g., fatigue), adherence expectation, and DMT self-efficacy. MS clinic staff will examine responses to weekly home monitoring assessment. They will provide telephone follow-up for medical advice, support, specific educational materials, and referral for services if necessary. Potential services will also be informed by Research Project 1, and will follow the general principle that they will be selected from a standardized list (e.g., additional injection training, energy management strategies for fatigue), but tailored to individual patient need based upon information obtained by home monitoring.
Primary outcome measures to assess feasibility will be the percentage of eligible participants who complete the study protocol, and comparisons between home monitoring recipients and controls regarding the overall benefits of participation. Outcomes will be assessed via monthly telephone calls.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98108
- VA Puget Sound Health Care System, Seattle
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Must have Multiple Sclerosis and be on a disease modifying therapy
Exclusion Criteria:
- Inability to participate in self-care
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: 1
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Behavioral counseling
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
adherence
기간: 3,6 months
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3,6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Aaron P. Turner, PhD, VA Puget Sound Health Care System, Seattle
간행물 및 유용한 링크
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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University Hospital, Montpellier종료됨제1형 당뇨병 | Basal-bolus multiple-dily 인슐린 주사 | 인슐린 펌프(CSII)프랑스