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
  Purpose

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 Intervention
Multiple Sclerosis
Behavioral: Self-management intervention
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self-management
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.
Behavioral: Education
Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944190

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Dawn Ehde, PhD University of Washington
Study Director: George Kraft, MD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00944190     History of Changes
Other Study ID Numbers: 36021-C, H133B080025
Study First Received: July 21, 2009
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
pain
fatigue
depression
cognitive difficulties
self-management

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014