e-health application for Aura

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alberta Health Services and The Governors of the University of Alberta, Edmonton, Canada
Aura+6 More
e-health application - Other
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a mobile app can help youth with brain-based disabilities to be more knowledgeable about their health.

See full description

Eligible Conditions

  • Aura
  • Cerebral Palsy
  • Autism Spectrum Disorder
  • Spina Bifida
  • Fetal Alcohol Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether e-health application will improve 1 primary outcome, 7 secondary outcomes, and 1 other outcome in patients with Aura. Measurement will happen over the course of Screen prior to Baseline and 6-Month Visit.

6-Month Visit
System Usability Scale (SUS)
Utilization of Intervention (Usage, Adherence, and Fidelity)
Baseline and 6-Month Visit
Canadian Occupational Performance Measure (COPM) Change
Health Utilities Index® (Hui2/3) Proxy-Assessed Change
Measure of Process of Care (MPOC) Change
Pediatric Quality of Life Instrument (PedsQL[TM]) Change
Resource Use Questionnaire (RUQ) Change
Transition Readiness Assessment Questionnaire (TRAQ) Change
Screen prior to Baseline and 6-Month Visit
TRANSITION-Q Change

Trial Safety

Trial Design

2 Treatment Groups

Control Group: Usual Care
1 of 2
Usual Care + MyREADYTransition[TM] BBD App
1 of 2
Active Control
Experimental Treatment

This trial requires 46 total participants across 2 different treatment groups

This trial involves 2 different treatments. E-health Application is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Usual Care + MyREADYTransition[TM] BBD App
Other
Participants in the experimental Intervention group continue to get the same care they have been getting (their usual care) and they receive the MyREADY Transition[TM] BBD App e-health application. There are 19 parts in the App with videos and games to help youth learn and practice ways to manage their health. There are approximately 5-7 hours of content in total. Participants will be asked to wait at least one day between the parts. There is a timer in the App to help to moderate pace and align with how young people learn and digest information. Participants can choose how much time they want to take to do the App. It is recommended that participants make their own routine for using it. The recommended shortest and longest intervention exposure times are: 1 part each day (this will take 19 days to do all of the App), 1 part each week (this will take 19 weeks to do all of the App).
Control Group: Usual CareParticipants in the no intervention Control group continue to get the same care they have been getting (their usual care). The researchers aim to supply the App to participants in both the intervention and control group for a limited time after participation in the study.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-month visit
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6-month visit for reporting.

Closest Location

Alberta Health Services and The Governors of the University of Alberta - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Youth with chronological age between 15 and 17 years of age (i.e. before 18th birthday), in one of the four Canadian study regions (Alberta, Ontario, Quebec, Maritimes), followed in pediatric care and for whom a discharge from pediatric care is planned but not for at least 6 months.
A diagnosis of one of the following neurological brain-based disabilities: autism spectrum disorder, cerebral palsy, epilepsy, spina bifida, or fetal alcohol spectrum disorder.
Cognitive ability to provide informed consent and the ability to read and understand English or French.
Access to internet and a smartphone, iPad/tablet or desktop computer.
TRANSITION-Q score >40 (as a screen to define a minimum threshold for transition readiness based on earlier work).

Patient Q&A Section

What are the signs of fetal alcohol syndrome?

"The presence of three or more of the following signs indicates a diagnosis of fetal alcohol syndrome: a height of less than the 45th percentile, facial anomalies, a smooth philtrum, small head, lowset ears, a midface hypoplasia, loose folds of skin on the arms and legs, and a heart defect. Other signs of fetal alcohol syndrome include fetal lethality and mental and physical handicaps in newborn infants. Alcohol consumption is associated with a lower IQ, speech impediments, delayed motor development, and diminished cognitive and emotional intelligence, making it imperative to educate people on the harmful effects of alcohol on the developing fetus." - Anonymous Online Contributor

Unverified Answer

Can fetal alcohol syndrome be cured?

"Results from a recent clinical trial of the present study do not support previous findings of spontaneous amelioration of FAS with ongoing prenatal alcohol exposure. Continued research in this area is necessary." - Anonymous Online Contributor

Unverified Answer

What is fetal alcohol syndrome?

"FAS is a condition in which alcohol is passed from the mother to the fetus, leading to birth defects. Symptoms are non-specific and can vary greatly, including neurodevelopmental anomalies. In most cases, the first symptoms are subtle and are not seen until the child is 2 to 3 years of age, long after the mother is diagnosed with alcohol dependence. There are many known causes of FAS but a known risk factor for this condition is a family member with alcohol dependence. The FAS guideline is available online." - Anonymous Online Contributor

Unverified Answer

What causes fetal alcohol syndrome?

"We have not proved any compelling evidence that prenatal alcohol exposure causes fetal alcohol syndrome, but studies on prenatal alcohol exposure were of fair quality. We cannot prove that these associations are causal and there is uncertainty if a causal relationship between alcohol intake and fetal alcohol syndrome exists. In addition, some investigators have concluded that most evidence that shows a causal link between alcohol use and fetal alcohol syndrome is of low methodological quality. A causal theory of fetal alcohol syndrome cannot be proven by good evidence of causation. Evidence of a direct link between maternal alcohol use and fetal alcohol syndrome cannot be proven either." - Anonymous Online Contributor

Unverified Answer

How many people get fetal alcohol syndrome a year in the United States?

"About 10,000 babies are born to alcoholic women each year in the United States. Those infants tend to be born prematurely, have multiple birth abnormalities, and have other malformations, compared to births to women who are not alcohol abusers. To reduce risk of harm to the fetus, many expectant alcoholic women are counseled to abstain from drinking alcohol, and many alcohol abusers are counseled not to drink alcoholic beverages during pregnancy. Those infants tend to be less likely to die before birth and are more likely to survive to reach adolescence than children who were born to alcohol abusers." - Anonymous Online Contributor

Unverified Answer

What are common treatments for fetal alcohol syndrome?

"The treatment goals of AAS vary greatly in their scope: eliminating and preventing alcohol-facilitated behavior, eliminating or reducing adverse physical consequences, or reducing a lifetime risk of liver disease. These goals may also include improving brain growth and brain development. A significant number of patients with FAS are on the autism spectrum. This may reflect the early onset of autism spectrum disorders because of FAS. The majority of children, who have milder behavioral disturbances, require behavioral therapy. Children with a high likelihood of a poor outcome (severe physical, mental, and intellectual disability) may have high-dose neuroleptic malignant syndrome prophylaxis. The treatment of severe FAS should be individualized depending on the patient's history." - Anonymous Online Contributor

Unverified Answer

What does e-health application usually treat?

"The treatment depends on the health problem and the health care providers in the hospital. While most studies of e-health use are to improve patient safety, most studies on e-health use are to improve the medical outcome and the health care. In some cases, e-health applications can improve the health care through enhancing patient safety. However, it is important to understand that e-health is the use of computers, phones, mobile phones, or Internet-connected telemedicine systems to assist in patient care processes and/or to control and monitor patient and health system activities." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating fetal alcohol syndrome?

"A new drug has been discovered that improves memory in those with fetal alcohol syndrome. This breakthrough is a significant advancement for treatment of those with this disease.\n" - Anonymous Online Contributor

Unverified Answer

Has e-health application proven to be more effective than a placebo?

"We conclude that our study demonstrates the e-health platform as an effective tool of delivering health messages during a period of crisis in a remote environment. Further investigation of the use of e-health and the use of telehealth in other health settings are needed." - Anonymous Online Contributor

Unverified Answer

Does fetal alcohol syndrome run in families?

"As many as one third of children with FAS have one or two family members with FAS. Thus, the risk for FAS appears to be familial, although a modifier gene may be involved. Recent findings provide a basis for further research into the genetics of the disease, and in particular the role of alcohol exposure in the genetic susceptibility to this complex disorder." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in e-health application for therapeutic use?

"The use of e-health technology for treating patients with rare diseases can be a valuable adjunct to improving the prognosis and efficiency of patient care by increasing the effectiveness of health care, thereby reducing time and cost." - Anonymous Online Contributor

Unverified Answer

Does e-health application improve quality of life for those with fetal alcohol syndrome?

"The e-health interventions were both found to be effective in improving HRQOL of individuals with FAS, with greater improvement found for those with higher FAS scores. In view of the positive findings, with regard to FAS, a wider e-health study is warranted, using the current methodology and measurement tools, including randomized, controlled trial design." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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