- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03574961
E-Support Groups in Multiple Sclerosis (eSupport)
A Randomized Controlled Trial of e-Support in Persons With Multiple Sclerosis
Primary objectives:
- To determine the feasibility of program (80% retained with 75% overall attendance, and completed immediate follow-up questionnaires from 75% of participants).
- To determine the efficacy of program (evaluated by decreased loneliness, operationalized as decreased total score on the UCLA Loneliness Scale from pre to post intervention).
Secondary objective:
- To determine whether program will affect depression and quality of life.
연구 개요
상세 설명
This study involves prospective data collection from an intervention to investigate the impact of participation by MS patients in a 12-week guided online social support group. All outcomes will be compared to active control group. At the completion of a 12-week interval, all participants (placebo and treatment) will complete follow-up questionnaires. Three months after completing, participants will be sent follow-up questionnaires that will be evaluated as a 6-month follow-up, to assess retention of benefits.
Social support has been linked to better health outcomes in many clinical populations. Multiple sclerosis (MS), a chronic neurological disease that affects over 400,000 people in the United States, involves physical and cognitive disability that can have negative consequences on social integration. This can lead to social isolation, which may be dynamically related to depression, fatigue, and disease progression. The aim of the present study is to investigate the impact of support group involvement on persons with MS. Outcomes of interest include mood, loneliness, and quality of life (QOL). Many people with MS feel isolated and are unable to participate in support groups that meet in locations that may be far from home, difficult to travel to (due to physical disability or lack of resources), or may not be convenient for their schedules. Another hindrance is the apprehension that MS patients sometimes experience when they encounter patients with severe physical disability, or worse impairment than their own. For these reasons, the study is introducing remote support groups to be conducted via the internet, "e-Support." Attending a remote, internet based support group may be more appealing to patients with MS as it obviates the need to travel, thereby reducing cost, time, and energy.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10032
- Columbia University Medical Center (MS Center)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of MS (any disease type)
- Age 18 or over
- Willingness to sign informed consent document
Exclusion Criteria:
- Unable to obtain access to the internet
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 |
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실험적: e-Support Group
Participants in this arm will receive the treatment, 12 weeks of 1-hr weekly moderated e-Support sessions.
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Online (remote), web-based support group via private video link.
다른 이름들:
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위약 비교기: e-Journaling Placebo
Participants in this arm will complete 12 weeks of 1-hr weekly online journaling activities.
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Online journaling activity.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of enrolled participants who completed follow-up questionnaires
기간: 12 weeks
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Assess feasibility of the program: to retain and obtain completed questionnaires at immediate follow-up from 80% of enrolled participants (meeting the criteria of 75% attendance).
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12 weeks
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Change in UCLA Loneliness Scale total score (please note that the official name of the scale is the UCLA Loneliness Scale).
기간: Baseline, 12 weeks (immediate follow-up)
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Assess efficacy of the program to decrease loneliness as defined by a significant decrease in total score on UCLA Loneliness Scale.
This name never appears as anything other than UCLA Loneliness Scale, i.e.
Russell 1996)
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Baseline, 12 weeks (immediate follow-up)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in overall depression [Patient Health Questionnaire (PHQ-9)] total score
기간: Baseline, 12 weeks
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Assess efficacy of the program to decrease depression as defined by a significant decrease in total score on Patient Health Questionnaire (PHQ-9): an efficient tool for depression screening.
The scale ranges from 0-27, with higher scores indicating worse depression.
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Baseline, 12 weeks
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Change in overall Functional Assessment of Multiple Sclerosis Quality of Life (FAMS QoL) score
기간: Baseline, 12 weeks
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Assess efficacy of the program to improve quality of life.
The Functional Assessment of Multiple Sclerosis (FAMS) quality of life (QoL) instrument is a disease-specific, self-report questionnaire.
It includes 7 subscales.
The total score is generated by summing scores across all subscales, and ranges from 0-232, with higher scores reflective or worse overall function.
In addition to considering a significant decrease in the total score as an indication of better overall function, we will separately examine each subscale to see whether decreases in score (indicating improvements in function) are shown.
This includes the following subscales: mobility, symptoms, emotional well-being, general contentment, thinking and fatigue, family/social well-being, and additional concerns scales.
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Baseline, 12 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Victoria M Leavitt, PhD, Columbia University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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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