Health Behavior Change in Chronic Disease Management
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In home monitoring with feedback
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Adherence, Medication, Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: - Must have Multiple Sclerosis and be on a disease modifying therapy Exclusion Criteria: - Inability to participate in self-care
Sites / Locations
- VA Puget Sound Health Care System, Seattle
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
adherence
Secondary Outcome Measures
Full Information
NCT ID
NCT00118547
First Posted
July 1, 2005
Last Updated
August 11, 2011
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00118547
Brief Title
Health Behavior Change in Chronic Disease Management
Official Title
Health Behavior Change in Chronic Disease Management
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
There is increasing recognition that coordinated approaches to disease management improve medication adherence. Intervention in chronic illness may be viewed as a multidisciplinary and collaborative process based upon behavioral principles, including the idea that illness management skills are learned and behavior is self-directed, motivation and self-efficacy can affect self care, monitoring and responding to changes in physical and mental health improves adaptation to illness, and the health care system can support or hinder self care. Preliminary findings suggest that telemedicine home monitoring providing cues to medication administration, brief evaluation of potential barriers (e.g., fatigue, cognition, side effects), identification of areas for future education (e.g., additional injection training), and an opportunity for feedback to providers (e.g., side effects) are well tolerated and may improve self monitoring of chronic medical conditions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Adherence, Medication, Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
In home monitoring with feedback
Intervention Description
Behavioral counseling
Primary Outcome Measure Information:
Title
adherence
Time Frame
3,6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Must have Multiple Sclerosis and be on a disease modifying therapy
Exclusion Criteria:
- Inability to participate in self-care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron P. Turner, PhD
Organizational Affiliation
VA Puget Sound Health Care System, Seattle
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System, Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19618711
Citation
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.
Results Reference
result
Learn more about this trial
Health Behavior Change in Chronic Disease Management
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