Infants, PrematureNCT02581800
Effect and Experience of PreHomeCare of Preterm Infants Using Telecommunication and Smartphone Application
A study testing App group in people with Infants, Premature and Breastfeeding, run by Mai-Britt Hägi-Pedersen at 4 sites in Denmark.
Trial summary
Background: Premature infants and their patents are discharged earlier from hospital and sent home in early in-homecare programs. Research regarding the use of health IT is needed to say, whether the use of videoconference and Smartphone application is a viable option to address the parents need for support in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infants, Premature, Breastfeeding, Telecommunication
- What is being tested?
- App group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 4 sitesDenmark
- Study dates
- Nov 2015to Oct 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
- Infants who fulfil criteria for early in-home care. GA > 34+0, No need for monitoring, tube feeding and started breastfeeding/bottle feeding, Danish speaking or English speaking patients (but understand the Danish text in the application).
Who cannot join
- Infants who do not fulfil criteria for early in-home care and parents, who require extra observation of the par-ent-infant relationship.
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Herning Neonatal
Herning, 7400
Neonatal
Næstved, 4700
Neonatal
Roskilde, 4000
Neonatal
Viborg, 8800
About this study
Official title: Effect and Experience of PreHomeCare of Preterm Infants Using Telecommunication and Smartphone Application: A Randomized Intervention Study.
Background: Premature infants and their patents are discharged earlier from hospital and sent home in early in-homecare programs. Research regarding the use of health IT is needed to say, whether the use of videoconference and Smartphone application is a viable option to address the parents need for support in relations to early discharge.
Aim: Test and explore early in-homecare (PreHomeCare) with videoconference and mobile application versus hospital consultations.
Read more
Method: Main study; a randomized controlled intervention study with the hypothesis; parent of premature infants who have access to electronic knowledge and participatory guidance 24-7: increases proportion of exclusive breastfeeding, Improves parent/infant interaction, enhances confidence and increases knowledge.
Sub study 1; a field study. Sub study 2; an interview study. Perspectives: It is expected that this project will be an argument in development of care for premature infants and telemedicine use in the future
Read the detailed description
Effect and experience of PreHomeCare of preterm infants using telecommunication and Smartphone application: A randomized intervention study.
Premature infants and their patents are discharged earlier from hospital and sent home in early in-homecare programs.
Effect studies of early in-homecare point towards that premature infants have lower risk of infections under the period of tube feeding, higher parental satisfaction and indicate that early in-homecare of premature infants benefit of home visits with fewer readmissions and less unscheduled support, shorter length of hospital stay and longer provision of breast milk. Standard procedure in early in-homecare is home visits but in regions of Denmark with large distances to the parent/infant this is not possible. No studies have until now offered 24-7 hours home visit support. Further research regarding the use of health IT is needed to say, whether the use of videoconference (participatory guidance) and Smartphone application (knowledge and data registration) is a viable option to address the parents need for support in relations to early discharge.
Main Study: A randomized controlled intervention study. The aim is to test the effect of the use of video communication and mobile application on exclusive breastfeeding, parent/infant interaction and parental confidence with the premature infants after PreHomeCare.
Hypothesis; Compared to parents of premature infants who receive hospital consultations, the parents of premature infants who have access to electronic knowledge and participatory guidance 24-7:
- Increases proportion of exclusive breastfeeding.
- Improves parent/infant interaction (MABISC-mother and baby interaction scale).
- Enhances the families' feeling of confidence in caring for their infant (KPCS - Karitane parenting confidence scale).
- Increases parent's knowledge with regarding the premature infant and the care. Parents will be randomized to either intervention or control group via simple randomization procedure.
The intervention group will receive a mobile application and videoconference system. The application contains three parts; 1) knowledge, 2) video contact/participatory guidance and 3) data registration.
Sample Size: Applying a significance level of 5%, a two-sided two-sample proportions test revealed that a sample size of 39 in each group maintains a power of 80% to detect the difference consisting of 55% vs. 40% breastfeeding women in the two groups after 4 weeks conditional on 66% breastfeeding at discharge. This corresponds to a sample size of 65 at randomisation. To compensate for the design effect ICC(0.01) the total sample size needed is thus approximately 160 preterm infants, 80 in each group.
Inclusion criteria: Infants who fulfil criteria for early in-home care. GA > 34+0, No need for monitoring, tube feeding and started breastfeeding/bottle feeding, Danish speaking or English speaking patents (but understand the Danish text in the application).
Exclusion criteria: Infants who do not fulfil criteria for early in-home care and parents, who require extra observations of the parent-infant relationship.
Data analysis; the results of the intervention and control group will be compared and analysed following "intention to treat" principle.
Qualitative evaluation:
Sub study 1: A field observational study: The aim is describe what characterizes nursing practice in PreHomeCare from the parents' angle in home around video consultations. Method will be based on Spradley "participant observation". The focus for the observation is the nurses' communication, how is her act on the screen etc. The field observations are expected to enlighten the characteristics of the nursing practice with a systematic description of PreHomeCare setting using video consultations. The prose text will be analysed following Ricoeur.
Sub study 2: An interview study: The aim is to explore how parents of premature infants experience PreHomeCare with use of video communication and mobile application. The study will be planned and conducted with inspiration from Kvale and Brinkmann´s instructions. The main focus for the interview will be to uncover the main question: "How did you experience PreHomeCare?" with a particular focus on what have been especially meaningful for the parents under PreHomeCare. The verbatim transcribed material will be analysed following Ricoeur interpretations theory.
Perspectives: This study will access new knowledge on the effect and experience with PreHomeCare. It will give insight in what is needed to make clear goals for the quality of the treatment and care for premature infants and parents in the last part of the admission/PreHomeCare. It is expected that this project will be an argument in further development of care for premature infants and telemedicine use in the future. The increased effectiveness can address challenges and help relocate economic and professional health services.
- Conditions
- Infants, Premature, Breastfeeding, Telecommunication, Patient Discharge, Nursing
- Being tested
- App group
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App groupOther
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group includes hospital consultations (usual care) on the hospital 2-3 times a week (1-2 hours) and the possibility to call the neonatal ward 24 hours a day all week until the infant gets full nutrition from the breast or bottle and gains weight. The parents register nutrition on a paper between the visits to the hospital. |
| App group/intervention group | Experimental | The intervention group will receive the Smartphone application at inclusion time and learn to use it in the hos-pital. When the families go home they will use the application and receive planned video consultations 2-3 times a week and the possibility to call the neonatal ward 24 hours a day all week whenever needed, until the infant gets full nutrition from the breast or bottle and gains weight. Parents will borrow a baby weight to weigh the baby at home. Receives: Other: App group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of breastfeeding
Measured: one month after discharge
Secondary outcomes (3)
Parents feeling of confidence
Measured: one month after discharge
Parent/child interaction
Measured: one month after discharge
Active knowledge concerning the premature infant
Measured: one month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infants, PrematureStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mai-Britt Hägi-Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mai-Britt Hägi-Pedersen, Naestved Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581800
- Sponsor's protocol ID
- PreHomeCare
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2015
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hagi-Pedersen MB, Dessau RB, Norlyk A, Stanchev H, Kronborg H. Comparison of video and in-hospital consultations during early in-home care for premature infants and their families: A randomised trial. J Telemed Telecare. 2022 Jan;28(1):24-36. doi: 10.1177/1357633X20913411. Epub 2020 Mar 30.
PubMed 32228143Hagi-Pedersen MB, Norlyk A, Dessau R, Stanchev H, Kronborg H. Multicentre randomised study of the effect and experience of an early inhome programme (PreHomeCare) for preterm infants using video consultation and smartphone applications compared with inhospital consultations: protocol of the PreHomeCare study. BMJ Open. 2017 Mar 9;7(3):e013024. doi: 10.1136/bmjopen-2016-013024.
PubMed 28279994
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Experience of PreHomeCare of Preterm Infants Using Telecommunication and Smartphone Application: A Randomized Intervention Study.
- ClinicalTrials.gov ID
- NCT02581800
- Acronym / sponsor ID
- PreHomeCare
- Conditions
- Infants, Premature, Breastfeeding, Telecommunication, Patient Discharge, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Mai-Britt Hägi-PedersenUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 21 Oct 2015 (estimated)
- 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.
Background: Premature infants and their patents are discharged earlier from hospital and sent home in early in-homecare programs. Research regarding the use of health IT is needed to say, whether the use of videoconference and Smartphone application is a viable option to address the parents need for support in relations to early discharge.
Aim: Test and explore early in-homecare (PreHomeCare) with videoconference and mobile application versus hospital consultations.
Method: Main study; a randomized controlled intervention study with the hypothesis; parent of premature infants who have access to electronic knowledge and participatory guidance 24-7: increases proportion of exclusive breastfeeding, Improves parent/infant interaction, enhances confidence and increases knowledge.
Sub study 1; a field study. Sub study 2; an interview study. Perspectives: It is expected that this project will be an argument in development of care for premature infants and telemedicine use in the future
Detailed description
Effect and experience of PreHomeCare of preterm infants using telecommunication and Smartphone application: A randomized intervention study.
Premature infants and their patents are discharged earlier from hospital and sent home in early in-homecare programs.
Effect studies of early in-homecare point towards that premature infants have lower risk of infections under the period of tube feeding, higher parental satisfaction and indicate that early in-homecare of premature infants benefit of home visits with fewer readmissions and less unscheduled support, shorter length of hospital stay and longer provision of breast milk. Standard procedure in early in-homecare is home visits but in regions of Denmark with large distances to the parent/infant this is not possible. No studies have until now offered 24-7 hours home visit support. Further research regarding the use of health IT is needed to say, whether the use of videoconference (participatory guidance) and Smartphone application (knowledge and data registration) is a viable option to address the parents need for support in relations to early discharge.
Main Study: A randomized controlled intervention study. The aim is to test the effect of the use of video communication and mobile application on exclusive breastfeeding, parent/infant interaction and parental confidence with the premature infants after PreHomeCare.
Hypothesis; Compared to parents of premature infants who receive hospital consultations, the parents of premature infants who have access to electronic knowledge and participatory guidance 24-7:
- Increases proportion of exclusive breastfeeding.
- Improves parent/infant interaction (MABISC-mother and baby interaction scale).
- Enhances the families' feeling of confidence in caring for their infant (KPCS - Karitane parenting confidence scale).
- Increases parent's knowledge with regarding the premature infant and the care. Parents will be randomized to either intervention or control group via simple randomization procedure.
The intervention group will receive a mobile application and videoconference system. The application contains three parts; 1) knowledge, 2) video contact/participatory guidance and 3) data registration.
Sample Size: Applying a significance level of 5%, a two-sided two-sample proportions test revealed that a sample size of 39 in each group maintains a power of 80% to detect the difference consisting of 55% vs. 40% breastfeeding women in the two groups after 4 weeks conditional on 66% breastfeeding at discharge. This corresponds to a sample size of 65 at randomisation. To compensate for the design effect ICC(0.01) the total sample size needed is thus approximately 160 preterm infants, 80 in each group.
Inclusion criteria: Infants who fulfil criteria for early in-home care. GA > 34+0, No need for monitoring, tube feeding and started breastfeeding/bottle feeding, Danish speaking or English speaking patents (but understand the Danish text in the application).
Exclusion criteria: Infants who do not fulfil criteria for early in-home care and parents, who require extra observations of the parent-infant relationship.
Data analysis; the results of the intervention and control group will be compared and analysed following "intention to treat" principle.
Qualitative evaluation:
Sub study 1: A field observational study: The aim is describe what characterizes nursing practice in PreHomeCare from the parents' angle in home around video consultations. Method will be based on Spradley "participant observation". The focus for the observation is the nurses' communication, how is her act on the screen etc. The field observations are expected to enlighten the characteristics of the nursing practice with a systematic description of PreHomeCare setting using video consultations. The prose text will be analysed following Ricoeur.
Sub study 2: An interview study: The aim is to explore how parents of premature infants experience PreHomeCare with use of video communication and mobile application. The study will be planned and conducted with inspiration from Kvale and Brinkmann´s instructions. The main focus for the interview will be to uncover the main question: "How did you experience PreHomeCare?" with a particular focus on what have been especially meaningful for the parents under PreHomeCare. The verbatim transcribed material will be analysed following Ricoeur interpretations theory.
Perspectives: This study will access new knowledge on the effect and experience with PreHomeCare. It will give insight in what is needed to make clear goals for the quality of the treatment and care for premature infants and parents in the last part of the admission/PreHomeCare. It is expected that this project will be an argument in further development of care for premature infants and telemedicine use in the future. The increased effectiveness can address challenges and help relocate economic and professional health services.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group includes hospital consultations (usual care) on the hospital 2-3 times a week (1-2 hours) and the possibility to call the neonatal ward 24 hours a day all week until the infant gets full nutrition from the breast or bottle and gains weight. The parents register nutrition on a paper between the visits to the hospital. |
| App group/intervention group | Experimental | Other: App groupThe intervention group will receive the Smartphone application at inclusion time and learn to use it in the hos-pital. When the families go home they will use the application and receive planned video consultations 2-3 times a week and the possibility to call the neonatal ward 24 hours a day all week whenever needed, until the infant gets full nutrition from the breast or bottle and gains weight. Parents will borrow a baby weight to weigh the baby at home. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Infants who fulfil criteria for early in-home care. GA > 34+0, No need for monitoring, tube feeding and started breastfeeding/bottle feeding, Danish speaking or English speaking patients (but understand the Danish text in the application).
Key exclusion criteria (1 listed)
- Infants who do not fulfil criteria for early in-home care and parents, who require extra observation of the par-ent-infant relationship.
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 |
|---|---|---|
| App group | Other | App group/intervention group |
Primary outcome
Proportion of breastfeeding
Time frame: one month after discharge
3 secondary outcomes
Parents feeling of confidence
Time frame: one month after discharge
Parent/child interaction
Time frame: one month after discharge
Active knowledge concerning the premature infant
Time frame: one month after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Derived from this study: PubMed 32228143Hagi-Pedersen MB, Dessau RB, Norlyk A, Stanchev H, Kronborg H. Comparison of video and in-hospital consultations during early in-home care for premature infants and their families: A randomised trial. J Telemed Telecare. 2022 Jan;28(1):24-36. doi: 10.1177/1357633X20913411. Epub 2020 Mar 30.
- Derived from this study: PubMed 28279994Hagi-Pedersen MB, Norlyk A, Dessau R, Stanchev H, Kronborg H. Multicentre randomised study of the effect and experience of an early inhome programme (PreHomeCare) for preterm infants using video consultation and smartphone applications compared with inhospital consultations: protocol of the PreHomeCare study. BMJ Open. 2017 Mar 9;7(3):e013024. doi: 10.1136/bmjopen-2016-013024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App group in people with Infants, Premature and Breastfeeding, run by Mai-Britt Hägi-Pedersen at 4 sites in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of breastfeeding (time frame: one month after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02581800, which also lists 2 linked publications.
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 12 Oct 2018.