NCT00118547

Brief Summary

The purpose of this pilot trial is to provide preliminary evidence of the effectiveness of a brief behavioral intervention using telemedicine home monitoring to help individuals with multiple sclerosis adhere to medications that slow disease progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2005

Typical duration 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

First Submitted

Initial submission to the registry

July 1, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 12, 2011

Status Verified

August 1, 2011

Enrollment Period

2 years

First QC Date

July 1, 2005

Last Update Submit

August 11, 2011

Conditions

Multiple Sclerosis

Keywords

AdherenceMedicationMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • adherence

    3,6 months

Study Arms (1)

1

OTHER
Behavioral: In home monitoring with feedback

Interventions

In home monitoring with feedbackBEHAVIORAL

Behavioral counseling

1

Eligibility Criteria

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

You may qualify if:

  • \- Must have Multiple Sclerosis and be on a disease modifying therapy

You may not qualify if:

  • \- Inability to participate in self-care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • Turner AP, Williams RM, Sloan AP, Haselkorn JK. Injection anxiety remains a long-term barrier to medication adherence in multiple sclerosis. Rehabil Psychol. 2009 Feb;54(1):116-21. doi: 10.1037/a0014460.

    PMID: 19618711RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Aaron P. Turner, PhD

    VA Puget Sound Health Care System, Seattle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 11, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

August 12, 2011

Record last verified: 2011-08

Locations

US(1)