Using Innovative Communication Technology to Improve the Health of Young African American Women
Virtual Patient Advocate (VPA)
Étude de prévention
Résumé
Date de début de l'étude : 1 septembre 2013
Date à laquelle le premier participant a commencé l'étude.The investigators will conduct a two-armed randomized controlled trial designed to enroll 530 African American women ages 18-34. After all subjects complete enrollment forms a comprehensive preconception health risk assessment, the intervention group will be trained to use the Gabby system and encouraged to use it at least monthly for one year.The control group will receive a letter listing the risks identified and they will be encouraged to see their clinician to discuss them. System Preparation: Dr. Bickmore and the technical team will be responsible for preparing the system for the trial, using the preconception care content and scripts developed by Dr. Jack and the research team. Both teams will meet as the working group to discuss final preparation and modifications. Usability Testing: As software development is complete, the investigators will conduct thorough usability testing of the interventions and the RCT protocols, using approximately 20 subjects who meet the enrollment criteria of the study. The subjects will use the Gabby system in the investigators research offices to complete the health risk assessment and to begin the interaction about individual risk factors. This session will last no more than one hour. Then they will use the Gabby system online in their home for two weeks; their interactions with the system will include: learning about their individual preconception health risks, managing their "My Health To-Do List," writing stories about their experiences with their health risks, and listening to stories left by other users. Usability subjects will be given a structured log sheet that lists each part of the intervention with space for them to record their reactions and concerns. Research staff (including representatives of both the technical and clinical staff) will review the log sheets. Then individual interviews examining their perceptions of the Gabby system will be conducted by Dr.Yinusa-Nyahkoon using a semi-structured interview guide (see attached Semi-Structured Interview Guide). Dr. Yinusa-Nyahkoon will recommend design and content changes based on interviews. These usability-testers will be paid for their participation and will not participate in the RCT. The investigators anticipate needing to implement a round of system modifications based on subject feedback. RCT: All RCT participants will be screened for eligibility criteria (see section 21), give consent to participate, and complete baseline data collection forms, including the online Preconception Health Risk Assessment. Randomization. Using a random numbers table, the statistician (Dr. Chetty) will prepare a numbered set of sealed study allocation envelopes prior to study start. Block randomization will be used to ensure that an equal number of subjects are randomized in each age group. The Control Group. The control group will receive a letter listing the preconception risks identified in the risk assessment and they will be encouraged to see their clinician to discuss them. The Intervention Group. Intervention participants from the RCT will be given a username and secure password to log on to the Gabby site for the 12 months of the intervention. They will be encouraged to log on at least monthly, but using the system is voluntary. They will be given the contact information of the Program Manager in the event that they have any issues or questions about the system. The research team will call each intervention participant after 12 months to conduct a follow-up phone call to collect outcome data. At that point, intervention participants will be invited to participate a focus group session, as described below. Focus Groups. Intervention participants from the RCT will be asked during their follow-up phone call if they would like to participate in a focus group. Each focus group session will last no more than 2 hours and will have no more than 10 participants; the investigators hope to enroll approximately 35 participants in total. Dr. Yinusa-Nyahkoon will conduct the focus group discussion to gather feedback about the system and suggestions for future improvement. All focus group participants will be invited to participate in an additional one-on-one individual interview with Dr. Yinusa-Nyahkoon. Individual Interviews. Dr. Yinusa-Nyahkoon will conduct the individual interviews using a semi-structured interview guide (see attached Semi-Structured Interview Guide). Each interview will last no more than one hour. All focus group participants will be eligible to sign up for an individual interviews; participation is voluntary. Interviews with Health Care Providers. Dr. Yinusa-Nyahkoon will conduct one-on-one interviews with health care providers. Only the providers of individual interview participants will be contacted by email for participation. Each health care provider interview will last no more than one hour. Applying the Intervention. After randomization, the study staff will provide a brief tutorial to the participants in the intervention group explaining how to use the Gabby system and provide a secure username and password to each participant. After completing the tutorial, the participant will be asked to interact with Gabby at least monthly for the next 12 months. They will be given the email address of the project staff so they can ask questions about how to use the system. The project staff will send an email to participants every two weeks to remind them to use the system. Twelve months after enrollment, study staff will call each participant to conduct a follow-up phone interview to collect outcome data.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.528 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 34 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Pas d'interventionObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site