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CHIME Study Case Report Forms

FORM NAME

FORM DETAILS

Form A: Screening Includes infant and mother medical history summarized from chart review to determine eligibility.

Collected: Once prior to study enrollment.

Annotated Form A

Form B: Family Interview Includes sociodemographic family information, maternal obstetric and medical history prior to and during pregnancy, and labor and delivery information.

Collected: Once after enrollment into the study.

Annotated Form B

Form C: Infant Medical History Includes neonatal information such as newborn physical measurements and gestational age, vaccinations and medications used prior to hospital discharge, systems functioning, infections and surgeries, and post discharge information including medical history, nutritional status, feeding history and sleeping habits.

Collected: Once after enrollment into the study.

Annotated Form C

Form D: Post-Enrollment Medical Follow-Up Includes interim medical information such as infant vaccination schedule, nutritional status, feeding and sleeping habits, as well as medications taken by the mother.

Collected: One month post enrollment, and at 44, 50, 56, 64, 72, 80 and 92 weeks PCA.

Annotated Form D

Form E: CHIME Hospitalization Review Form Includes information about infant hospitalization such as dates of hospitalization, reason for hospitalization, diagnostic studies, treatment and final diagnosis at discharge from the hospital.

Collected: Following EACH hospitalization, including any pre-enrollment hospitalizations which may have followed initial newborn discharge.

Form H1: CHIME Monitor Confidence Scale Includes caregiver self-reported confidence in performing activities related to home monitoring such as applying electrodes, remembering to turn monitor on, etc.

Collected: One month post enrollment and at 44, 50, 56, 64, 72, 80, and 92 weeks PCA.

Annotated Form H1

Form H2-Weekly: Weekly Contact Includes information about the preceding week including monitor alarms, medical contacts, outpatient diagnostics, illnesses not requiring medical attention, medication use, daycare and home monitor use.

Collected: Weekly

Form H2-Missed: Missed Weekly Contact Includes information about weeks during which the H2-Weekly Form was not successfully completed such as infant breathing, hospitalization and outpatient diagnostics.

Collected: For each time interval where an H2-Weekly was not completed.

Annotated Form H2-Missed

Form H2-Phone: CHIME Phone Contact Report Includes information pertaining to the CHIME montitor and technical support provided such as family concerns, responses to these concerns, and any supplies necessary for continued monitoring.

Collected: Weekly, if a visit was not completed, and anytime phone contact was made regarding support for the CHIME monitor.

Annotated Form H2-Phone

Form H2-Visit: CHIME Monitor Report Includes information pertaining to the CHIME montitor and technical support provided such as family concerns, responses to these concerns, and any supplies necessary for continued monitoring.

Collected: Weekly, if phone contact was not completed, and anytime a visit was necessary to provide support for the CHIME monitor.

Annotated Form H2-Visit

Form H4: CHIME Monitor Satisfaction Scale Includes caregiver report of satisfaction with the CHIME monitor such as ease of use and/or problems that may have arisen.

Collected: One month post enrollment and at 44, 50, 56, 64, 72, 80 and 92 weeks PCA.

Form H6: CHIME Knowledge Evaluation Form Includes 10 multiple choice questions regarding caregiver's knowledge of home monitoring.

Collected: After initial montiro training, at the one month post-intake visit, and at the second medical follow-up visit.

Form I: CHIME Completion of Monitoring Form Includes information such as the dates of home monitor use, the reason for monitor ending and participation in other studies.

Collected: Once after study has been completed.

Form K1: Feelings About Parenting Includes information such as the caregiver's feelings toward the infant, toward restrictions imposed by parenting  and toward their own competence in the parental role.

Collected: At 44 and 56 weeks PCA.

Form K2: Parenting Stress Index Depression Subscale Includes measures of parental depression and emotional availability as well as information pertaining to prior family problems.

Collected: At 44, 56 and 92 weeks PCA.

Bayley Mental Scale Record Form Includes assessments of infant sensory-perceptual activity such as object constancy, memory, learning, problem solving and verbal ability.

Collected: At 44, 56, and 92 weeks PCA. These dates are adjusted for pre and post maturity.

Bayley Motor Scale Record Form Includes assessments of infant muscle control, gross motor coordination and fine motor coordination.

Collected: At 44, 56, and 92 weeks PCA. These dates are adjusted for pre and post maturity.

Bayley Behavior Rating Scale Record Form Includes assessments of infant attitude, interest, emotion, energy, activity, and response to stimuli.

Collected: At 44, 56, and 92 weeks PCA. These dates are adjusted for pre and post maturity.

Feeding Scale Includes assessment of parent-child interaction during an observed feeding session.

Collected: At 44, and 56 weeks PCA. 

Teaching Scale Includes assessment of parent-child interaction during an observed teaching situation where the parent is asked to teach the child a specific task.

Collected: At 92 weeks PCA.

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Funded by NICHD grant# 2U10HD2906709A1.
For problems or questions regarding this web contact [Project Email].
Last updated: June 24, 2004.