Changes in Adherence After Playing "My Life With CF" Game
Recruitment status was Recruiting
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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. |
- 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 ]
- 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 |
Inclusion Criteria:
- patients with a diagnosis of CF
- age 12 - 20 years
- capable of reading and conversing in English
- capable and willing to provide assent for study participation
- presence of a parent/guardian capable of providing informed consent
Exclusion Criteria:
- absence of a parent/guardian or unwillingness to provide permission
- potential participant declines to provide assent
- 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| Contact: Kathy Christenson, RN CPNP | 816-234-3705 | kchristenson@cmh.edu |
| 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 | |
| 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 May 23, 2013