MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-04-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will conduct an initial clinical evaluation of this support program to examine its impact on reducing caregiver stress, increasing confidence in daily feeding, and improving weight-for-age growth percentiles in infants with Congenital Heart Disease (CHD).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The National Program for the Improvement of Management of Fetal Congenital Heart Disease in China

NCT05940363

Congenital Heart Disease in Pregnancy Prenatal Diagnosis Fetal Echocardiography

NOT_YET_RECRUITING

A Family Intervention for Improving Self-Care of Patients With Heart Failure

NCT00645489

Heart Failure, Congestive

COMPLETED EARLY_PHASE1

Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients

NCT00000557

Cardiovascular Diseases Coronary Disease Depression +3 more

COMPLETED PHASE3

Heart Failure Educational and Follow up Platform

NCT02110433

Chronic Heart Failure

COMPLETED NA

CHF Management Using Telemedicine

NCT00309764

Congestive Heart Failure (CHF)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Caregivers of infants with CHD are at high-risk of anxiety and distress due to the complex daily caregiving demands. Previous research has demonstrated decreased parental stress and more optimal infant developmental outcomes with a psychosocial intervention delivered to caregivers of infants with CHD prior to hospital discharge as well as reduced healthcare use in caregivers who received medical video-consultations during the interstage surgical palliation period. This study will implement a telemedicine intervention program (MyHeartBaby) to support caregivers remotely in the daily care and adjustment to having an infant with chronic medical needs. The program is delivered via video chat over the Internet and caregivers will complete questionnaires about general family information, stress, and feeding their infant.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MyHeartBaby

Caregivers will complete Telehealth Psychosocial Sessions and 4 follow up assessments.

Group Type EXPERIMENTAL

MyHeartBaby Program

Intervention Type BEHAVIORAL

Participating Caregivers will receive an electronic tablet loaded with a telemedicine intervention program (MyHeartBaby) to support caregivers remotely in the daily care and adjustment to having an infant with chronic medical needs with video-based telemedicine support services. There are a total of six sessions occurring at weeks 3, 6, 9, 12, and 15 of the study.

Standard of Care

Caregivers will complete 4 follow up assessments.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MyHeartBaby Program

Participating Caregivers will receive an electronic tablet loaded with a telemedicine intervention program (MyHeartBaby) to support caregivers remotely in the daily care and adjustment to having an infant with chronic medical needs with video-based telemedicine support services. There are a total of six sessions occurring at weeks 3, 6, 9, 12, and 15 of the study.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Caregiver's infant is less than 45 days of age at time of study enrollment.
* Caregiver of infant with high-risk, shunt dependent physiology (one or two-ventricle circulation) having just received neonatal surgery for CHD.
* English is a primary language for caregiver of infant.

Exclusion Criteria

* Caregiver's infant is greater than 45 days of age at time of study enrollment.
* Not a caregiver of infant with high-risk, shunt dependent physiology having just received neonatal surgery for CHD.
* English is not a primary language for caregiver of infant.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes