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Clinical Trials/NCT01832064
NCT01832064
Completed
Not Applicable

Development of a Mailed Chronic Disease Self-Management Program

Stanford University1 site in 1 country255 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Diseases
Sponsor
Stanford University
Enrollment
255
Locations
1
Primary Endpoint
Health Status (symptoms, activity limitation)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
July 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • active cancer treatment

Outcomes

Primary Outcomes

Health Status (symptoms, activity limitation)

Time Frame: six months

Secondary Outcomes

  • Metabolic control (HbA1c)(six months)
  • health behavior (exercise, communication with physician)(six months)
  • Health care utilization(six months)

Study Sites (1)

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