TakeCharge: Telephone Delivered Self-management Intervent... | NCT00944190

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

NCT00944190

Sponsor

University of Washington

Status

Completed

Last Update Posted

Apr 7, 2015Estimated

Enrollment

166Actual

Phase

Not Applicable

Conditions

Multiple Sclerosis

Interventions

Self-management intervention
Education

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H133B080025	Other Grant/Funding Number	NIDRR

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jul 21, 2009

First Submission Date that Met QC Criteria

Jul 21, 2009

First Posted Date

Jul 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dawn Ehde, Professor, Rehabilitation Medicine, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Self-management intervention	Behavioral	Brief counseling technique, self-management,	Self-management Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dawn Ehde, PhD	University of Washington	Principal Investigator
George Kraft, MD	University of Washington	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington		Seattle	Washington	98195	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42423672	Derived	Phillips Reindel KM, Bell AS, Goldberg EL, Green C, Watson ST, Ehde DM. Exploring social moderators of telehealth treatment outcomes for adults with multiple sclerosis: A secondary analysis of a randomized controlled trial. Rehabil Psychol. 2026 Jul 9. doi: 10.1037/rep0000686. Online ahead of print.
33196779	Derived

Type	Date	Date Unknown
Release	Sep 11, 2019
Reset	Oct 1, 2019

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

ID	Term
D009103	Multiple Sclerosis
D010146	Pain
D005221	Fatigue
D003863	Depression