Active Living Tool Kit for Chronic Conditions

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01832064
• Collaborator: (none)
• Enrollment: 255
• Location: 1
• Arm: 1
• Duration (Months): 13
• Patients Per Site Per Month: 19.6

Study Details

Study Description

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	Phase
Chronic Diseases	Behavioral: Mailed Chronic Disease Self-Management Program	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 255 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Development of a Mailed Chronic Disease Self-Management Program
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Health Status (symptoms, activity limitation) [six months]

Secondary Outcome Measures

1. Metabolic control (HbA1c) [six months]

   For subset of participants with type 2 diabetics

2. health behavior (exercise, communication with physician) [six months]

3. Health care utilization [six months]

   MD, emergency, hospital times and total nights

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicien	Stanford	California	United States	94306

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Kate Lorig, DPH, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT01832064
• Other Study ID Numbers: 26610
• First Posted: Apr 15, 2013
• Last Update Posted: Jul 31, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Stanford University: chronic disease; patient education; self management
• Additional relevant MeSH terms: Chronic Disease

Study Results

No Results Posted as of Jul 31, 2014