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Active Living Tool Kit for Chronic Conditions

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. Identifier: NCT01832064
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):
Stanford University

Brief Summary:
The development and pilot testing of a self-management program that would be delivered in a one time mailing.

Condition or disease Intervention/treatment
Chronic Diseases Behavioral: Mailed Chronic Disease Self-Management Program

Detailed Description:

The mailing will consist of (1) A self-test that will help users know how he or she can best use the materials and where to start; (2) A copy of the 2012 Living Healthy Life with Chronic Conditions book. If people are visually impaired or have low literacy an audio CD of the book will be available in place of the print copy; (3)An exercise CD with flexibility and strengthening exercises at three different levels of intensity, designed for people with chronic conditions; (4) A relaxation CD with three different relaxation exercises; and (5) In addition, there will be tip sheets, one for each major tool such as managing pain, managing sleep, etc. It is expected that there will be 10-20 tip sheets in total.

The key content of the self-test and the tip sheets will be developed surveying master trainers of the existing small-group Chronic Disease Self Management Program (100 active trainers) and asking about 500 additional trainers to rank importance of key content items generated in initial survey. Pilot testing of the program will be by 250 people with chronic diseases. Participants will be surveyed by mailed questionnaires at baseline and six-months. A subgroup with diabetes (estimated 25-30%) will be asked to submit hemoglobin A1C blood test kits at baseline and six months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Development of a Mailed Chronic Disease Self-Management Program
Study Start Date : June 2013
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mailed Chronic Disease Self-Management
Mailed Chronic Disease Self-Management Program: self management information and self assessment
Behavioral: Mailed Chronic Disease Self-Management Program
materials are mailed to participants

Primary Outcome Measures :
  1. Health Status (symptoms, activity limitation) [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Metabolic control (HbA1c) [ Time Frame: six months ]
    For subset of participants with type 2 diabetics

  2. health behavior (exercise, communication with physician) [ Time Frame: six months ]
  3. Health care utilization [ Time Frame: six months ]
    MD, emergency, hospital times and total nights

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a chronic health condition
  • 18 years of age
  • Literate in English
  • (for the blood test subset): have type 2 diabetes

Exclusion Criteria:

  • Taken the small group or online Chronic Disease Self Management Program or related programs
  • under 18
  • active cancer treatment
  • pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01832064

United States, California
Stanford University School of Medicien
Stanford, California, United States, 94306
Sponsors and Collaborators
Stanford University
Principal Investigator: Kate Lorig, DPH Stanford University

Additional Information:
Responsible Party: Stanford University Identifier: NCT01832064     History of Changes
Other Study ID Numbers: 26610
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by Stanford University:
chronic disease
patient education
self management

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes