Changes in Adherence After Playing "My Life With CF" Game

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Children's Mercy Hospital Kansas City.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00688051
First received: May 28, 2008
Last updated: May 30, 2008
Last verified: May 2008
  Purpose

Nonadherence to treatment regimes among patients with cystic fibrosis (CF) is well documented in the literature. Unfortunately, few interventions have been successful at improving adherence rates in this patient population. Within the pediatric population, specifically adolescents, attitude toward treatment directly effects adherence to treatment. Changing attitude includes making conscious decisions regarding adherence or non-adherence and should include an understanding of what outcomes will likely result from nonadherence.

This study will determine if attitudes can be enhanced and adherence to treatment regimen improved in Cystic Fibrosis (CF) adolescent patients by using a simulation game "My Life with CF" . The target population is CF patients ages 12-21 years. Attitudes will be assessed utilizing four attitude scales in CF adolescents pre and post experiencing the simulation game. In the simulation game, patients make life decisions, including CF therapy decisions, using a fictional character diagnosed with CF. The game has been designed to help players understand the long-term effects of health care choices. Data from this pilot study will assess changes in attitudes and reported changes in adherence.


Condition Intervention
Cystic Fibrosis
Other: My Life with CF game

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Changes in Adherence to Diet, Treatment and Medication in the Cystic Fibrosis Patient as a Result of Participation in a Simulation Game.

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • To determine changes in attitude associated with playing the game "My Life with CF". [ Time Frame: One month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine changes in frequency to adherence of treatment plan, specifically related to respiratory treatments and medications, one month after playing the game "My Life with CF". [ Time Frame: One month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: My Life with CF game
Play the game My Life with CF
Other Name: My Life with CF

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. patients with a diagnosis of CF
  2. age 12 - 20 years
  3. capable of reading and conversing in English
  4. capable and willing to provide assent for study participation
  5. presence of a parent/guardian capable of providing informed consent

Exclusion Criteria:

  1. absence of a parent/guardian or unwillingness to provide permission
  2. potential participant declines to provide assent
  3. the presence of a healthcare condition that does not meet infection control standards (i.e. patients with burkodalia cepacia) for participation in the small group setting necessary to play the game.
  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: NCT00688051

Contacts
Contact: Kathy Christenson, RN CPNP 816-234-3705 kchristenson@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Kathy Christenson, RN CPNP    816-234-3705    kchristenson@cmh.edu   
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Kathy Christenson, RN CPNP Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Kathy Christenson, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00688051     History of Changes
Other Study ID Numbers: 07 06-091E
Study First Received: May 28, 2008
Last Updated: May 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Cystic Fibrosis
Adherence to treatment

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014