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

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Jeanne Hoffman, University of Washington
ClinicalTrials.gov Identifier:
NCT00693563
First received: June 5, 2008
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Spinal Cord Injury
Behavioral: Scheduled Telephone Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Scheduled Telephone Intervention for Individuals With Spinal Cord Injury and Their Families: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Counts of rehospitalizations (frequency and duration), emergency department visits, and clinic visits to address medical complications [ Time Frame: one year ] [ Designated as safety issue: No ]

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 [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: August 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
The Control Group will receive usual care following discharge from the inpatient rehabilitation unit.
Experimental: Treatment Group
Scheduled Telephone Intervention
Behavioral: Scheduled Telephone Intervention
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693563

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Jeanne Hoffman
U.S. Department of Education
Investigators
Principal Investigator: Charles Bombardier, PhD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Jeanne Hoffman, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00693563     History of Changes
Other Study ID Numbers: 32148-G
Study First Received: June 5, 2008
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Spinal Cord Injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 21, 2014