Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2005-09-30
2007-09-30
Brief Summary
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Detailed Description
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The proposed study is a six-month, two group parallel-design, controlled trial to evaluate feasibility and obtain effect size estimates for a behavioral intervention to improve adherence to MS disease modifying therapy (DMT) using telemedicine home monitoring. Monitoring will include brief weekly text-based prompting to complete a series of approximately 10-15 questions regarding factors that are expected to affect adherence to DMT. Areas of assessment will include the development of side effects (e.g., flu-like symptoms), disease specific symptoms (e.g., fatigue), adherence expectation, and DMT self-efficacy. MS clinic staff will examine responses to weekly home monitoring assessment. They will provide telephone follow-up for medical advice, support, specific educational materials, and referral for services if necessary. Potential services will also be informed by Research Project 1, and will follow the general principle that they will be selected from a standardized list (e.g., additional injection training, energy management strategies for fatigue), but tailored to individual patient need based upon information obtained by home monitoring.
Primary outcome measures to assess feasibility will be the percentage of eligible participants who complete the study protocol, and comparisons between home monitoring recipients and controls regarding the overall benefits of participation. Outcomes will be assessed via monthly telephone calls.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
In home monitoring with feedback
Behavioral counseling
Interventions
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In home monitoring with feedback
Behavioral counseling
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Department of Veterans Affairs
Principal Investigators
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Aaron P. Turner, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System, Seattle
Locations
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VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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B3319V
Identifier Type: -
Identifier Source: org_study_id
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