Changes in Adherence to Diet, Treatment and Medication in the Cystic Fibrosis Patient as a Result of Participation in a Simulation Game.

Thirty patients will be enrolled in the study. These volunteer individuals will complete the Attitude Assessment Scale and Diet and Treatment form, play the game and provide demographic data. They will complete the Attitude Assessment Scales again following the game and debriefing. These individuals will complete the Attitude Assessment Scale and Diet and Treatment form a third time, one month after playing the game. Historical review indicates that enrollment for the study can be completed within 10 months after IRB approval is secured. This allows all aspects of the study to be complete within the one year time frame established by the funding agency.

Participants for this study will be identified using study inclusion / exclusion criteria Inclusion criteria are: 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, and 5) presence of a parent/guardian capable of providing informed consent. Exclusion criteria are: 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. Patients with MRSA will not be excluded from the study. Patients with MRSA can play the game alone, with a CMH staff member, study personnel, or sibling. All infection control measures will be followed according to hospital policy. Members of the study team have identified patients, based on inclusion criteria, who will qualify for the study. A letter will be mailed to these patients with a description of the game, study purpose, and time requirement. A follow-up phone call will be made by a member of the study team to arrange a time when the patient can play the game. Any questions related to study participation will be answered. Consent/assent will be obtained prior to filling out the paper work at the start of the game session.

When a patient is identified for study inclusion, a study investigator will explain the study to the parent/legal guardian and the child. If both these individuals express a willingness to participate, a copy of the informed consent/assent form will be given to them. After both the parent/guardian and child have read and signed the consent/assent form, a copy will be given to each of them and placed in the medical record. The original informed consent/assent form will be kept by the PI with all study materials. The study uses a convenience sampling methodology so no unique study number will be used.

3. Treatment Groups

There are no treatment groups for this study. Participants will complete an Attitude Assessment Scale and Diet and Treatment form prior to playing the game and complete the Attitude Assessment Scales immediately after the game and debriefing. The Attitude Assessment Scales and Diet and Treatment form will also be filled out again one month after playing the game. In addition, these individuals will provide self-disclosed demographic data, which will be used only to describe the study population.