Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Health Behavior Change in Chronic Disease Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00118547
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : August 12, 2011
Sponsor:
Information provided by:
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE July 1, 2005
First Posted Date  ICMJE July 11, 2005
Last Update Posted Date August 12, 2011
Study Start Date  ICMJE September 2005
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
adherence [ Time Frame: 3,6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2005)
Adherence to DMT at follow-up months 1-6
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2005)
Quality of Life at follow-up months 1-6
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Behavior Change in Chronic Disease Management
Official Title  ICMJE Health Behavior Change in Chronic Disease Management
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Behavioral: In home monitoring with feedback
Behavioral counseling
Study Arms  ICMJE 1
Intervention: Behavioral: In home monitoring with feedback
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2008)
20
Original Enrollment  ICMJE
 (submitted: July 7, 2005)
50
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

- Inability to participate in self-care

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00118547
Other Study ID Numbers  ICMJE B3319V
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Turner, Aaron - Principal Investigator, Department of Veterans Affairs
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aaron P. Turner, PhD VA Puget Sound Health Care System, Seattle
PRS Account VA Office of Research and Development
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP