Active Living Tool Kit for Chronic Conditions

Not Applicable

Completed

• Conditions: Chronic Diseases
• Interventions: Behavioral: Mailed Chronic Disease Self-Management Program

• Registration Number: NCT01832064
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-15
• Study Start: 2013-06
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mailed Chronic Disease Self-Management	Mailed Chronic Disease Self-Management Program	Mailed Chronic Disease Self-Management Program: self management information and self assessment

Primary Outcome Measures

Name	Time	Method
Health Status (symptoms, activity limitation)	six months

Secondary Outcome Measures

Name	Time	Method
Metabolic control (HbA1c)	six months	For subset of participants with type 2 diabetics
health behavior (exercise, communication with physician)	six months
Health care utilization	six months	MD, emergency, hospital times and total nights

Trial Locations

Locations (1)

Stanford University School of Medicien; 🇺🇸 Stanford, California, United States