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

Spinal Cord Injury Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693563
• Other study ID #: 32148-G
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: January 10, 2013
• Start date: August 2007
• Est. completion date: October 2011

Study information

• Verified date: January 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Jeanne Hoffman	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Counts of rehospitalizations (frequency and duration), emergency department visits, and clinic visits to address medical complications		one year	No
Secondary	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	No

External Links

•   Northwest Regional Spinal Cord Injury System