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

NCT00944190 | Completed

• 2 other identifiers: 36021-CH133B080025
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

pain; fatigue; depression; cognitive difficulties; self-management

Outcome Measures

Primary Outcomes (3)

• PHQ 9

  Baseline, 5 weeks, 10 weeks, 6 months, and 12 months

• Brief Pain Inventory

  Baseline, 5 weeks, 10 weeks, 6 months, and 12 months

• Modified Fatigue Impact Scale

  Baseline, 5 weeks, 10 weeks, 6 months, 12 months

Secondary Outcomes (3)

• PROMIS Depression Short Form

  Baseline, 5 weeks, 10 weeks, 6 months, 12 months

• PROMIS Pain Impact Short Form

  Baseline, 5 weeks, 10 weeks, 6 months, 12 months

• PROMIS Fatigue Short Form

  Baseline, 5 weeks, 10 weeks, 6 months, 12 months

Study Arms (2)

Self-management Intervention

EXPERIMENTAL

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

Behavioral: Self-management intervention

Education

ACTIVE COMPARATOR

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

Behavioral: Education

Interventions

Self-management intervention BEHAVIORAL

Brief counseling technique, self-management,

Self-management Intervention

Education BEHAVIORAL

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

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• 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.

  PMID: 33196779 DERIVED

• 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.

  PMID: 29337024 DERIVED

• 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.

  PMID: 26254948 DERIVED

Related Links

• Webpage for MS Rehabilitation Research and Training Center

MeSH Terms

Conditions

Multiple Sclerosis; Pain; Fatigue; Depression

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Dawn Ehde, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• George Kraft, MD

  University of Washington

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 23, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: September 1, 2013
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)