TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00944190
First received: July 21, 2009
Last updated: November 8, 2012
Last verified: November 2012

July 21, 2009
November 8, 2012
October 2009
September 2013   (final data collection date for primary outcome measure)
  • PHQ 9 [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Brief Pain Inventory [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Modified Fatigue Impact Scale [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00944190 on ClinicalTrials.gov Archive Site
  • PROMIS Depression Short Form [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • PROMIS Pain Impact Short Form [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • PROMIS Fatigue Short Form [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS)
Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties

The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is hypothesized that if the effects of these conditions are reduced, study participants will demonstrate improved participation in the community and improved employment outcomes. This project is important because the majority of persons with MS experience one or more of the following secondary conditions: fatigue, pain, depression, and cognitive impairment. These secondary conditions are not always readily apparent and constitute what has been described by our Rehabilitation Research and Training Center as "hidden disabilities." Secondary conditions such as pain, depression, fatigue, and cognitive impairment frequently not only cause distress in their own right but also affect employment, participation, and quality of life. Having more than one often compounds the effect; the effect of all may be greater than the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment can worsen depression).

It is critical that this constellation of secondary symptoms be addressed using state of the art techniques based on self-management training and that intervention effects be documented with carefully controlled treatment efficacy studies.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Behavioral: Self-management intervention
    Brief counseling technique, self-management,
  • Behavioral: Education
    Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
  • Experimental: Self-management
    Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
    Intervention: Behavioral: Self-management intervention
  • Active Comparator: Education
    Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
    Intervention: Behavioral: Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
September 2014
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be diagnosed with MS by a physician.
  • Must be at least 18 years of age.
  • Must be able to understand, speak, and read English.
  • Must have the presence of at least one of four common secondary conditions (fatigue, pain, depression, cognitive difficulties) that interferes with employment, participation, and functioning.

Exclusion Criteria:

  • Unable to understand or read English.
  • Severe cognitive impairment, defined as one or more errors on the 6-item screener, that would prevent informed consent and inability to carry on a phone conversation.
  • Currently participating in regularly scheduled psychotherapy.
  • Psychiatric contraindications such as current psychosis, active suicidal ideation, or current alcohol or drug use.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00944190
36021-C, H133B080025
No
University of Washington
University of Washington
Not Provided
Principal Investigator: Dawn Ehde, PhD University of Washington
Study Director: George Kraft, MD University of Washington
University of Washington
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP