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

NCT00693563 | Completed

• 1 other identifier: 32148-G
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (1)

• 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 Arms (2)

Control Group

NO INTERVENTION

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

Treatment Group

EXPERIMENTAL

Scheduled Telephone Intervention

Behavioral: Scheduled Telephone Intervention

Interventions

Scheduled Telephone Intervention BEHAVIORAL

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jeanne Hoffman: lead
• U.S. Department of Education: collaborator

Study Sites (2)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Links

• Northwest Regional Spinal Cord Injury System

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Charles Bombardier, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: August 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

US (2)