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Clinical Trials/NCT00693563
NCT00693563
Completed
N/A

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

Jeanne Hoffman2 sites in 1 country168 target enrollmentAugust 2007

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
Jeanne Hoffman
Enrollment
168
Locations
2
Primary Endpoint
Counts of rehospitalizations (frequency and duration), emergency department visits, and clinic visits to address medical complications
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
October 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jeanne Hoffman
Responsible Party
Sponsor Investigator
Principal Investigator

Jeanne Hoffman

Associate Professor

University of Washington

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

Outcomes

Primary Outcomes

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

Time Frame: one year

Secondary Outcomes

  • 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)

Study Sites (2)

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