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临床试验/NCT03574961
NCT03574961已完成不适用

A Randomized Controlled Trial of e-Support in Persons With Multiple Sclerosis

Columbia University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Percentage of enrolled participants who completed follow-up questionnaires

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of MS (any disease type)
  • •Age 18 or over
  • •Willingness to sign informed consent document

排除标准

  • •Unable to obtain access to the internet

研究组 & 干预措施

e-Support Group

Experimental

Participants in this arm will receive the treatment, 12 weeks of 1-hr weekly moderated e-Support sessions.

干预措施: e-Support group (Behavioral)

e-Journaling Placebo

Placebo Comparator

Participants in this arm will complete 12 weeks of 1-hr weekly online journaling activities.

干预措施: e-Journaling placebo (Behavioral)

结局指标

主要结局

Percentage of enrolled participants who completed follow-up questionnaires

时间窗: 12 weeks

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).

Change in UCLA Loneliness Scale total score (please note that the official name of the scale is the UCLA Loneliness Scale).

时间窗: Baseline, 12 weeks (immediate follow-up)

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)

次要结局

  • Change in overall Functional Assessment of Multiple Sclerosis Quality of Life (FAMS QoL) score(Baseline, 12 weeks)
  • Change in overall depression [Patient Health Questionnaire (PHQ-9)] total score(Baseline, 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria M. Leavitt

Assistant Professor of Neuropsychology (in Neurology and Gertrud, Dept of Neur Neuropsychology

Columbia University

研究点 (1)

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