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

NCT00688051 | Completed DMC

• 1 other identifier: 07 06-091E
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Adherence to treatment

Outcome Measures

Primary Outcomes (1)

• To determine changes in attitude associated with playing the game "My Life with CF".

  One month follow up

Secondary Outcomes (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".

  One month follow up

Study Arms (1)

1

EXPERIMENTAL

Other: My Life with CF game

Interventions

My Life with CF game OTHER

Play the game My Life with CF

Also known as: My Life with CF

1

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Health Behavior; Behavior

Study Officials

• Kathy Christenson, RN CPNP

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterologist

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

US (1)