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NCT03975530 · ClinicalTrials.gov registry record · NA
Piloting a Precision Approach to Home Visiting
A NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
NCT03975530 is a NA study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 66 participants.
The verdict
NCT03975530, a NA study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
Study Summary
The proposed study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Sites in both groups will use an electronic platform to support implementation. The investigators will select four sites and randomize two of them to standard Family Spirit and two to precision Family Spirit. Sites will be matched based on annual volume of clients served and geographic similarity (i.e. urban vs. rural). All participating sites will be trained in the electronic implementation support platform. The two sites randomized to provide the precision approach will receive additional training on how to provide it. In each site, all new clients who are prenatal or up to 2-months postpartum will be offered participation in the study. The study will then follow them until 12 months postpartum and measure outcomes during this time (see measurement table below). Qualitative interviews with precision participants will be done at 6 and 12 months postpartum. Focus group discussions with home visitors will also be completed during regular study team meetings. Analysis of study instruments (basic psychometrics based on baseline and end line data) and preliminary differences between the sites on Aim 3 and 4 outcomes will be done in December 2019 assuming the investigators have achieved their estimated sample size with enough retention for 6-months post enrollment. Dissemination of results will be done upon completion of the analysis.
Interventions
- BEHAVIORAL Precision Family Spirit
- BEHAVIORAL Standard Family Spirit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2020-12-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03975530
The ClinicalTrials.gov registry entry for NCT03975530 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Precision Family Spirit is the first listed.
NCT03975530 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03975530 about?
NCT03975530 is a clinical study titled "Piloting a Precision Approach to Home Visiting". The proposed study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Sites in both grou...
What is the current status of trial NCT03975530?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2019-06-24. Estimated completion is 2020-12-18.
What interventions are being tested in trial NCT03975530?
The interventions under investigation include: Precision Family Spirit (BEHAVIORAL), Standard Family Spirit (BEHAVIORAL).
Who is sponsoring clinical trial NCT03975530?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
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