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

NCT ID: NCT00693563

Last Updated: 2013-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-10-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment Group

Scheduled Telephone Intervention

Group Type: EXPERIMENTAL

Scheduled Telephone Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

Jeanne Hoffman

OTHER

Sponsor Role: lead

Responsible Party

Jeanne Hoffman

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Charles Bombardier, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Related Links

http://sci.washington.edu

Northwest Regional Spinal Cord Injury System

Other Identifiers

32148-G

Identifier Type: -

Identifier Source: org_study_id