Parent Mental HealthNCT05282368
Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis
A study testing PHM™ Pathway in people with Parent Mental Health, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to test and evaluate the Preparing Heart and Mind™ (PHM™) patient engagement pathway as a nurse-guided intervention to lower psychological distress and enhance caregiving competencies among mothers/birthing persons and their caregiving partners after a major fetal anomaly diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parent Mental Health
- What is being tested?
- PHM™ Pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 1 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A study participant can include a pregnant person past 20 weeks of pregnancy (this includes a vulnerable population)
- Willing and able to comply with study procedures.
- Participants must be ≥ 18 years old.
- Participants must be able to read, write and speak English.
- Participants must have access, and ability to use a smartphone, tablet, or computer in a private location.
- The pregnant woman/person and her caregiving partner are planning for infant delivery and care.
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- The fetal diagnosis of the major anomaly affects the heart (i.e., CCHD). See definition of CCHD included earlier in the protocol. Other anomalies could be present and potentially impair other organs.
- The infant's anomaly will likely require surgical and/or medical intervention within the first year of life.
- The fetus/infant is expected to live with surgical and/or medical intervention (this includes a vulnerable population).
- There may be genetic and/or chromosomal conditions in addition to the heart/structural anomalies
Who cannot join
- Pregnancy termination
- The fetal anomaly diagnosis is highly likely to result in fetal or infant demise shortly after birth.
- Adults lacking the capacity to consent
- Adults who do not have access to a smart phone, tablet, or device.
- Caregiving partner cannot enroll if mother is not enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The purpose of this study is to test and evaluate the Preparing Heart and Mind™ (PHM™) patient engagement pathway as a nurse-guided intervention to lower psychological distress and enhance caregiving competencies among mothers/birthing persons and their caregiving partners after a major fetal anomaly diagnosis.
- Conditions
- Parent Mental Health
- Being tested
- PHM™ Pathway
- Keywords
- parent, fetal anomaly, prenatal diagnosis, infant, heart disease, ehealth, intervention
- Medical subject headings
- Congenital Abnormalities, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHM™ PathwayBehavioural
The technological platform referred to as Preparing Heart and Mind™ (PHM™) is designed as a patient engagement pathway. This platform includes GetWellNetwork's proprietary workflow engine, Patient Pathways™ and functionality of the Health Loop platform. Specifically, PHM™ will be created on a customized GetWellNetwork patient engagement pathway, getwell | Loop, which is a secure platform with a parent-facing app and an interactive dashboard for healthcare providers. The PHM™ getwell | Loop is a care program with chapters that incorporate interactive resources for patient information and education, trackers as touch points for psycho-social/educational support, and tailors care with condition-specific content, as well as action items.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (PHM) | Experimental | This pathway is intended to be a tool to enhance support for a mother/birthing person and her caregiving partner, facilitate communication with healthcare providers, and promote development of caregiving to optimize maternal-fetal, infant, and family health. Receives: Behavioral: PHM™ Pathway |
| Usual Care Group (UC) | No intervention | The control group participants will receive care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State-Trait Anxiety Inventory score
State subscale, 20 items, 4-point scale; State Anxiety cut point score ≥40
Measured: 12 weeks after birth
Change in Center for Epidemiology Scale-Depression (CES-D) score
20 items, 4-point scale; cut point score ≥16
Measured: 12 weeks after birth
Change in Impact of Event Scale score
22 items, 4-point scale; cut point score ≥ 24
Measured: 12 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Nov 2020
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent Mental HealthStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Model description
- This small pilot study is designed as a mixed methods randomized controlled trial to estimate and test the effect of a nurse-guided PHM™ intervention on psychological distress and perceived caregiving competencies using longitudinal, repeated measures. Qualitative and quantitative data are expected to provide crucial insights regarding app usage patterns, interactions with the nurse interventionist, and impacts of the intervention on the individual/dyad.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne C McKechnie, PhD, RN, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282368
- Sponsor's protocol ID
- SON-2019-27260
- Status last verified
- Apr 2023
- First submitted
- 7 Feb 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Heart and Mind™: A Patient Engagement Pathway for Parents and Their Caregiving Partners After a Major Fetal Anomaly Diagnosis
- ClinicalTrials.gov ID
- NCT05282368
- Acronym / sponsor ID
- SON-2019-27260
- Conditions
- Parent Mental Health
- Keywords
- parent, fetal anomaly, prenatal diagnosis, infant, heart disease, ehealth, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 16 Mar 2022 (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.
The purpose of this study is to test and evaluate the Preparing Heart and Mind™ (PHM™) patient engagement pathway as a nurse-guided intervention to lower psychological distress and enhance caregiving competencies among mothers/birthing persons and their caregiving partners after a major fetal anomaly diagnosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This small pilot study is designed as a mixed methods randomized controlled trial to estimate and test the effect of a nurse-guided PHM™ intervention on psychological distress and perceived caregiving competencies using longitudinal, repeated measures. Qualitative and quantitative data are expected to provide crucial insights regarding app usage patterns, interactions with the nurse interventionist, and impacts of the intervention on the individual/dyad.
| Arm | Type | Receives |
|---|---|---|
| Intervention (PHM) | Experimental | Behavioral: PHM™ PathwayThis pathway is intended to be a tool to enhance support for a mother/birthing person and her caregiving partner, facilitate communication with healthcare providers, and promote development of caregiving to optimize maternal-fetal, infant, and family health. |
| Usual Care Group (UC) | No intervention | –The control group participants will receive care as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A study participant can include a pregnant person past 20 weeks of pregnancy (this includes a vulnerable population)
- Willing and able to comply with study procedures.
- Participants must be ≥ 18 years old.
- Participants must be able to read, write and speak English.
- Participants must have access, and ability to use a smartphone, tablet, or computer in a private location.
Key exclusion criteria (5 listed)
- Pregnancy termination
- The fetal anomaly diagnosis is highly likely to result in fetal or infant demise shortly after birth.
- Adults lacking the capacity to consent
- Adults who do not have access to a smart phone, tablet, or device.
- Caregiving partner cannot enroll if mother is not enrolled
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 |
|---|---|---|
| PHM™ PathwayThe technological platform referred to as Preparing Heart and Mind™ (PHM™) is designed as a patient engagement pathway. This platform includes GetWellNetwork's proprietary workflow engine, Patient Pathways™ and functionality of the Health Loop platform. Specifically, PHM™ will be created on a customized GetWellNetwork patient engagement pathway, getwell | Loop, which is a secure platform with a parent-facing app and an interactive dashboard for healthcare providers. The PHM™ getwell | Loop is a care program with chapters that incorporate interactive resources for patient information and education, trackers as touch points for psycho-social/educational support, and tailors care with condition-specific content, as well as action items. | Behavioural | Intervention (PHM) |
Primary outcome
Change in State-Trait Anxiety Inventory score
Time frame: 12 weeks after birth
State subscale, 20 items, 4-point scale; State Anxiety cut point score ≥40
Change in Center for Epidemiology Scale-Depression (CES-D) score
Time frame: 12 weeks after birth
20 items, 4-point scale; cut point score ≥16
Change in Impact of Event Scale score
Time frame: 12 weeks after birth
22 items, 4-point scale; cut point score ≥ 24
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 1 May 2023.
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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.
Anne C McKechnie, PhD, RN principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHM™ Pathway in people with Parent Mental Health, run by University of Minnesota at 1 site in United States.
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 10 inclusion and 5 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 1 May 2023. 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 United States. 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?
Change in State-Trait Anxiety Inventory score (time frame: 12 weeks after birth). The study lists 3 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 1 May 2023.