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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688051
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : September 5, 2014
Information provided by (Responsible Party):
Craig A. Friesen, MD, Children's Mercy Hospital Kansas City

Brief Summary:

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 or disease Intervention/treatment Phase
Cystic Fibrosis Other: My Life with CF game Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: 1 Other: My Life with CF game
Play the game My Life with CF
Other Name: My Life with CF

Primary Outcome Measures :
  1. To determine changes in attitude associated with playing the game "My Life with CF". [ Time Frame: One month follow up ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00688051

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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
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Principal Investigator: Kathy Christenson, RN CPNP Children's Mercy Hospital Kansas City
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Responsible Party: Craig A. Friesen, MD, Pediatric Gastroenterologist, Children's Mercy Hospital Kansas City Identifier: NCT00688051    
Other Study ID Numbers: 07 06-091E
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014
Keywords provided by Craig A. Friesen, MD, Children's Mercy Hospital Kansas City:
Cystic Fibrosis
Adherence to treatment
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases