Changes in Adherence After Playing "My Life With CF" Game
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): My Life with CF game
Intervention type(s): Other
Intervention description(s): Play the game My Life with CF
Other intervention name(s): My Life with CF
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Adherence to treatment