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

4. Drugs/Devices/Experimental Intervention:

The experimental intervention includes playing the game "My Life with CF."

Each participant will complete an assessment regarding diet and treatment adherence, and
attitudes toward behaviors associated with 1) belief that luck rather than effort determines
what happens to a person in life, 2) belief in personal invulnerability, and 3) making life
decisions without including long-term consequences. After the baseline measure has been
obtained, participants will play the "My Life with CF" game. The attitude assessment scales
will be repeated after the game and debriefing. The attitude assessment scales and Diet and
Treatment form will be repeated one month following the game.

5. Observations and Measurements

Participants will be asked to complete the "Attitude Assessment Scales provided in Appendix
B. Attitude Scales 1,2 and 3 are the attitude scales validated for the "My Life" game.
Attitude scale 4 was created specifically for the "My Life with CF" game and has not been
validated. Each attitude scale has 20 questions and is based on a likert-type scale with 1
strongly disagree to 5 strongly agree. The first three attitude scales focus on the three
attitudes which have been shown to influence decision making during adolescence. Attitude
scale number one assesses personal invulnerability, attitude scale number two assesses
present versus future considerations, and attitude scale number three measures luck versus
effort. Attitude scale number 4 has an equal number of questions from the above three
categories which are specific to CF.

Data collection will occur through the utilization of a "My Life with CF" Case Report Form
provided in Appendix C. All study participants' personal health information will be kept
confidential in compliance with Federal Law and institutional guidelines. All research case
report forms will be kept in Kathy Christenson's office within a secured cabinet and
destroyed in accordance with policy and procedures in place regarding research data.

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.