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临床试验/NCT00693563
NCT00693563已完成不适用

Scheduled Telephone Intervention for Individuals With Spinal Cord Injury and Their Families: A Randomized Controlled Trial

Jeanne Hoffman4 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
168
试验地点
4
主要终点
Counts of rehospitalizations (frequency and duration), emergency department visits, and clinic visits to address medical complications

研究概览

简要总结

The purpose of this study is to evaluate whether scheduled telephone intervention with individuals with spinal cord injury (SCI) and their caregivers in the first year following discharge from acute inpatient rehabilitation will reduce rehospitalizations and emergency room visits as well as improve adjustment to SCI.

详细描述

This project is a two-group randomized control trial. The control group will receive usual care given to all patients being discharged from acute inpatient rehabilitation following SCI. At 6 months and one year post injury an examiner blinded to group status will contact Control Group participants to collect outcome data.

The Telephone Intervention group (Treatment Group) will also receive their usual care following discharge and a welcome letter, which will include the same information as the Control Group, but also remind them of the up-coming telephone call schedule. Treatment Group participants and their significant others will be contacted by telephone within 24 to 48 hours after discharge and 10 additional times at weeks 1, 2, 4, 6, and months 2, 3, 4, 6, 8, and 10. The frequent early telephone contacts are meant to address early concerns that frequently arise after discharge are expected to last between 30 and 45 minutes. Later phone calls may be brief if no concerns are raised and are expected to address resource needs as well as ongoing questions that arise through the first year after injury. Content of each phone call will be dependent on issues raised by each individual participant and their significant other and/or follow-up on concerns raised in prior phone contacts rather than a specific structured interview. Treatment Group participants will also be contacted at 6 months and one year post injury by the examiner blinded to group status to collect outcome data.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • new traumatic SCI
  • inpatient acute rehabilitation at the SCI system hospital
  • residence in the catchment area at the time of injury

排除标准

  • lack of a telephone
  • non-English speaking
  • severe psychiatric condition such as psychosis

结局指标

主要结局

Counts of rehospitalizations (frequency and duration), emergency department visits, and clinic visits to address medical complications

时间窗: one year

次要结局

  • Composite of 4 measures to assess adjustment to SCI: Center for Epidemiologic Studies-Depression Scale (CES-D)79; Perceived Quality of Life (PQOL)80; Craig Handicap and Reporting Technique (CHART)81; Health-Promoting Lifestyle Profile II82(one year)

研究者

发起方
Jeanne Hoffman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeanne Hoffman

Associate Professor

University of Washington

研究点 (4)

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