Active Living Tool Kit for Chronic Conditions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01832064
First received: April 11, 2013
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Chronic Diseases
Behavioral: Mailed Chronic Disease Self-Management Program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Development of a Mailed Chronic Disease Self-Management Program

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Health Status (symptoms, activity limitation) [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolic control (HbA1c) [ Time Frame: six months ] [ Designated as safety issue: No ]
    For subset of participants with type 2 diabetics

  • health behavior (exercise, communication with physician) [ Time Frame: six months ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: six months ] [ Designated as safety issue: No ]
    MD, emergency, hospital times and total nights


Estimated Enrollment: 250
Study Start Date: June 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • under 18
  • active cancer treatment
  • pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832064

Locations
United States, California
Stanford University School of Medicien
Stanford, California, United States, 94306
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Kate Lorig, DPH Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01832064     History of Changes
Other Study ID Numbers: 26610
Study First Received: April 11, 2013
Last Updated: October 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
chronic disease
patient education
self management

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014