AnxietyNCT03554512
TelePremie: Telehomecare for Step-down Care Post-NICU Discharge
A study testing Telehealth virtual appointment in people with Anxiety and Self Efficacy, run by Horizon Health Network at 1 site in Canada.
Trial summary
Telehealth is a means of providing care from a distance, at the convenience of the patient. This study will be testing the addition of Telehealth visits (TH) to the standard of care (SOC) following discharge from the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anxiety, Self Efficacy
- What is being tested?
- Telehealth virtual appointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent-infant pairs admitted to neonatal intensive care unit where study is conducted.
- Parent has internet access.
- Parent has literacy level such that they are comfortable reading and filling out surveys.
- Infant is likely to survive.
Who cannot join
- Infant discharged to foster care.
- Infant transferred or discharged within 3 days of admission to neonatal intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
Telehealth is a means of providing care from a distance, at the convenience of the patient. This study will be testing the addition of Telehealth visits (TH) to the standard of care (SOC) following discharge from the neonatal intensive care unit (NICU). This study will be used to determine whether Telehealth appointments post-NICU discharge can improve the experiences of parents in caring for their infant and reduce the number of health care visits they have with their infant within three months post-NICU discharge.
Participants in this study will be randomly assigned to two groups. One group will receive the standard of care, which means they will have an appointment in place with a primary care provider, pediatrician or return visit to the NICU post discharge. The second group will have the standard of care described above and two Telehealth visits within the first week at home with their infant.
Read more
The study will explore the experiences of parents of NICU infants following their discharge from NICU, both those receiving standard of care (SOC) and the Telehealth monitoring intervention. Participants will be required to complete surveys online at 5 time periods: when parents decide to be part of the study, prior to discharge from NICU, 1 day after discharge, 2 days following the primary care provider visit and at 3 months following discharge from NICU. The questionnaires used will measure parental anxiety levels and parental confidence. The number of infant visits to the primary care provider, pediatrician, emergency department and NICU will also be collected at three months post-NICU discharge.
A subset of participants (from both SOC and TH groups) will further participate in semi-structured interviews about their experiences in the NICU and caring for their children after discharge. NICU clinicians who consent will participate in semi-structured interviews about their experiences with the Telehealth intervention.
The cost-effectiveness of the Telehealth intervention will be analysed in comparison to SOC.
- Conditions
- Anxiety, Self Efficacy
- Being tested
- Telehealth virtual appointment
- Keywords
- Neonatal Intensive Care, Telehealth, Anxiety, Self Efficacy, Parenting/psychology
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth virtual appointmentOther
Appointment with NICU clinician via telehealth equipment.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | No Intervention |
| Telehealth | Experimental | Telehealth virtual appointment Receives: Other: Telehealth virtual appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory
Measured: Change from Baseline State-Trait Anxiety at 3 months
The Maternal Confidence Questionnaire
Measured: Change from Baseline self-efficacy at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Jul 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- Canada Health Infoway
- Responsible party
- Sponsor
- Investigators
- Cecil Ojah, MD, Principal investigator, Horizon Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554512
- Sponsor's protocol ID
- CHSTHCHHN02
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TelePremie: Telehomecare for Step-down Care Post-NICU Discharge
- ClinicalTrials.gov ID
- NCT03554512
- Acronym / sponsor ID
- CHSTHCHHN02
- Conditions
- Anxiety, Self Efficacy
- Keywords
- Neonatal Intensive Care, Telehealth, Anxiety, Self Efficacy, Parenting/psychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Collaborators
- Canada Health Infoway
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Telehealth is a means of providing care from a distance, at the convenience of the patient. This study will be testing the addition of Telehealth visits (TH) to the standard of care (SOC) following discharge from the neonatal intensive care unit (NICU). This study will be used to determine whether Telehealth appointments post-NICU discharge can improve the experiences of parents in caring for their infant and reduce the number of health care visits they have with their infant within three months post-NICU discharge.
Participants in this study will be randomly assigned to two groups. One group will receive the standard of care, which means they will have an appointment in place with a primary care provider, pediatrician or return visit to the NICU post discharge. The second group will have the standard of care described above and two Telehealth visits within the first week at home with their infant.
The study will explore the experiences of parents of NICU infants following their discharge from NICU, both those receiving standard of care (SOC) and the Telehealth monitoring intervention. Participants will be required to complete surveys online at 5 time periods: when parents decide to be part of the study, prior to discharge from NICU, 1 day after discharge, 2 days following the primary care provider visit and at 3 months following discharge from NICU. The questionnaires used will measure parental anxiety levels and parental confidence. The number of infant visits to the primary care provider, pediatrician, emergency department and NICU will also be collected at three months post-NICU discharge.
A subset of participants (from both SOC and TH groups) will further participate in semi-structured interviews about their experiences in the NICU and caring for their children after discharge. NICU clinicians who consent will participate in semi-structured interviews about their experiences with the Telehealth intervention.
The cost-effectiveness of the Telehealth intervention will be analysed in comparison to SOC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –No Intervention |
| Telehealth | Experimental | Other: Telehealth virtual appointmentTelehealth virtual appointment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parent-infant pairs admitted to neonatal intensive care unit where study is conducted.
- Parent has internet access.
- Parent has literacy level such that they are comfortable reading and filling out surveys.
- Infant is likely to survive.
Key exclusion criteria (2 listed)
- Infant discharged to foster care.
- Infant transferred or discharged within 3 days of admission to neonatal intensive care unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth virtual appointmentAppointment with NICU clinician via telehealth equipment. | Other | Telehealth |
Primary outcome
The State-Trait Anxiety Inventory
Time frame: Change from Baseline State-Trait Anxiety at 3 months
The Maternal Confidence Questionnaire
Time frame: Change from Baseline self-efficacy at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecil Ojah, MD principal investigator
Horizon Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth virtual appointment in people with Anxiety and Self Efficacy, run by Horizon Health Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The State-Trait Anxiety Inventory (time frame: Change from Baseline State-Trait Anxiety at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.