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Scheduled Telephone Intervention for Individuals With Spinal Cord Injury and Their Families (SCILink)

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scheduled Telephone Intervention
Sponsored by
Jeanne Hoffman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injury focused on measuring Spinal Cord Injury

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Harborview Medical Center
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

The Control Group will receive usual care following discharge from the inpatient rehabilitation unit.

Scheduled Telephone Intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 5, 2008
Last Updated
January 10, 2013
Sponsor
Jeanne Hoffman
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT00693563
Brief Title
Scheduled Telephone Intervention for Individuals With Spinal Cord Injury and Their Families
Acronym
SCILink
Official Title
Scheduled Telephone Intervention for Individuals With Spinal Cord Injury and Their Families: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeanne Hoffman
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The Control Group will receive usual care following discharge from the inpatient rehabilitation unit.
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Scheduled Telephone Intervention
Intervention Type
Behavioral
Intervention Name(s)
Scheduled Telephone Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Counts of rehospitalizations (frequency and duration), emergency department visits, and clinic visits to address medical complications
Time Frame
one year
Secondary Outcome Measure Information:
Title
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
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: new traumatic SCI inpatient acute rehabilitation at the SCI system hospital residence in the catchment area at the time of injury Exclusion Criteria: lack of a telephone non-English speaking severe psychiatric condition such as psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Bombardier, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Links:
URL
http://sci.washington.edu
Description
Northwest Regional Spinal Cord Injury System

Learn more about this trial

Scheduled Telephone Intervention for Individuals With Spinal Cord Injury and Their Families

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