TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS) (TakeCharge)
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|ClinicalTrials.gov Identifier: NCT00944190|
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : April 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Self-management intervention Behavioral: Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||September 2013|
Experimental: Self-management Intervention
Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
Behavioral: Self-management intervention
Brief counseling technique, self-management,
Active Comparator: Education
Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
- PHQ 9 [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months ]
- Brief Pain Inventory [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months ]
- Modified Fatigue Impact Scale [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ]
- PROMIS Depression Short Form [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ]
- PROMIS Pain Impact Short Form [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ]
- PROMIS Fatigue Short Form [ Time Frame: Baseline, 5 weeks, 10 weeks, 6 months, 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944190
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Dawn Ehde, PhD||University of Washington|
|Study Director:||George Kraft, MD||University of Washington|