NCT01198977

Brief Summary

This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 12, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 9, 2019

Status Verified

September 1, 2019

Enrollment Period

5.9 years

First QC Date

September 8, 2010

Results QC Date

August 9, 2016

Last Update Submit

September 24, 2019

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisFatigueexercisetelemedicinemotivational interviewingcounselingdepressionphysical activity

Outcome Measures

Primary Outcomes (1)

  • Fatigue

    Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.

    baseline, 3 months, 6 months

Secondary Outcomes (1)

  • Depression

    baseline, 3 months, 6 months

Other Outcomes (1)

  • Physical Activity (Behavioral Target)

    baseline, 3 months, 6 months

Study Arms (2)

Brief telephone-based counseling

ACTIVE COMPARATOR

Telephone based counseling and instructional video

Behavioral: Brief telephone-based counseling

Education Counseling

PLACEBO COMPARATOR

Mailed Physical Activity information and instructional video only

Other: Education counseling

Interventions

Brief telephone-based counselingBEHAVIORAL

Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving

Brief telephone-based counseling
Education counselingOTHER

Mailed informational video of exercise programs

Education Counseling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multiple Sclerosis
  • Veteran receiving services in VA VISN 20
  • Fatigue
  • Ability to ambulate
  • cell phone or Household phone line
  • Individual with multiple sclerosis verified by MS provider
  • ambulatory

You may not qualify if:

  • Current alcohol dependence or other substance dependence
  • No working phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (2)

  • Turner AP, Hartoonian N, Sloan AP, Benich M, Kivlahan DR, Hughes C, Hughes AJ, Haselkorn JK. Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. J Consult Clin Psychol. 2016 Apr;84(4):297-309. doi: 10.1037/ccp0000086. Epub 2016 Feb 25.

    PMID: 26913621RESULT

  • Turner AP, Hartoonian N, Hughes AJ, Arewasikporn A, Alschuler KN, Sloan AP, Ehde DM, Haselkorn JK. Physical activity and depression in MS: The mediating role of behavioral activation. Disabil Health J. 2019 Oct;12(4):635-640. doi: 10.1016/j.dhjo.2019.04.004. Epub 2019 Apr 30.

    PMID: 31097413DERIVED

Related Links

MeSH Terms

Conditions

Multiple SclerosisFatigueMotor ActivityDepression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBehavioral Symptoms

Limitations and Caveats

Only ambulatory individuals were enrolled, thus high exclusion rate due to ambulation status. Outcome and mediating variables measured by validated self-report methods. A broad range of physical activity levels were included (most were low).

Results Point of Contact

Title
Aaron Turner, PhD, Director, Rehabilitation Psychology; Asst Director Research, MSCOE
Organization
Rehabilitation Care Services; MS Center of Excellence (MSCOE), VA Puget Sound Health Care System
Aaron.Turner@med.va.gov
206-277-6134

Study Officials

  • Aaron P Turner, PhD

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 10, 2010

Study Start

October 1, 2009

Primary Completion

September 1, 2015

Study Completion

December 1, 2016

Last Updated

October 9, 2019

Results First Posted

August 12, 2016

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)