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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-management intervention
Education
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring pain, fatigue, depression, cognitive difficulties, self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-management Intervention

Education

Arm Description

Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.

Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.

Outcomes

Primary Outcome Measures

PHQ 9
Brief Pain Inventory
Modified Fatigue Impact Scale

Secondary Outcome Measures

PROMIS Depression Short Form
PROMIS Pain Impact Short Form
PROMIS Fatigue Short Form

Full Information

First Posted
July 21, 2009
Last Updated
April 6, 2015
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00944190
Brief Title
TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS)
Acronym
TakeCharge
Official Title
Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
pain, fatigue, depression, cognitive difficulties, self-management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-management Intervention
Arm Type
Experimental
Arm Description
Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
Intervention Type
Behavioral
Intervention Name(s)
Self-management intervention
Intervention Description
Brief counseling technique, self-management,
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
Primary Outcome Measure Information:
Title
PHQ 9
Time Frame
Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Title
Brief Pain Inventory
Time Frame
Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
Title
Modified Fatigue Impact Scale
Time Frame
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
Secondary Outcome Measure Information:
Title
PROMIS Depression Short Form
Time Frame
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
Title
PROMIS Pain Impact Short Form
Time Frame
Baseline, 5 weeks, 10 weeks, 6 months, 12 months
Title
PROMIS Fatigue Short Form
Time Frame
Baseline, 5 weeks, 10 weeks, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Ehde, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Kraft, MD
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33196779
Citation
Knowles LM, Arewasikporn A, Kratz AL, Turner AP, Alschuler KN, Ehde DM. Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis. Ann Behav Med. 2021 Aug 23;55(9):833-843. doi: 10.1093/abm/kaaa102.
Results Reference
derived
PubMed Identifier
29337024
Citation
Ehde DM, Arewasikporn A, Alschuler KN, Hughes AJ, Turner AP. Moderators of Treatment Outcomes After Telehealth Self-Management and Education in Adults With Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1265-1272. doi: 10.1016/j.apmr.2017.12.012. Epub 2018 Jan 11.
Results Reference
derived
PubMed Identifier
26254948
Citation
Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.
Results Reference
derived
Links:
URL
http://msrrtc.washington.edu
Description
Webpage for MS Rehabilitation Research and Training Center

Learn more about this trial

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

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