Active Living Tool Kit for Chronic Conditions

Chronic Diseases Clinical Trial

Official title:

Development of a Mailed Chronic Disease Self-Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832064
• Other study ID #: 26610
• Status: Completed
• Phase: N/A
• First received: April 11, 2013
• Last updated: July 29, 2014
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

Intervention

Behavioral:
• Mailed Chronic Disease Self-Management Program
materials are mailed to participants

Locations

Country	Name	City	State
United States	Stanford University School of Medicien	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Status (symptoms, activity limitation)		six months	No
Secondary	Metabolic control (HbA1c)	For subset of participants with type 2 diabetics	six months	No
Secondary	health behavior (exercise, communication with physician)		six months	No
Secondary	Health care utilization	MD, emergency, hospital times and total nights	six months	No

External Links

•   Summary of Chronic Disease Self-Management Program, including citations