Active Living Tool Kit for Chronic Conditions

July 29, 2014 updated by: Stanford University

Development of a Mailed Chronic Disease Self-Management Program

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94306
        • Stanford University School of Medicien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health Status (symptoms, activity limitation)
Time Frame: six months
six months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Kate Lorig, DPH, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 11, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26610

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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