- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05280951
Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana (Focused-PPC)
The purpose of this project is to test and evaluate an innovative postpartum care, education, and support model that integrates recommended clinical care, education, and support for women in a group setting.
Aim 1. Develop an innovative integrated group postpartum care, education, and support model entitled Focused-PPC for postpartum women up to one year after delivery.
Aim 2. Implement and evaluate this integrated postpartum care model entitled Focused-PPC in a parallel randomized controlled trial with 192 postpartum women at 4 health centers in Tamale, Ghana.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Principal Investigator
- Numéro de téléphone: +1 574 631 3224
- E-mail: yadams@nd.edu
Lieux d'étude
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Tamale, Ghana
- Recrutement
- Bagabaga Health Center
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Contact:
- Project Manager
- Numéro de téléphone: +233243601588
- E-mail: emefa@savsign.org
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Tamale, Ghana
- Recrutement
- Choggu Health Center
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Contact:
- Project Manager
- Numéro de téléphone: +233243601588
- E-mail: emefa@savsign.org
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Tamale, Ghana
- Recrutement
- Kalpohin Health Center
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Contact:
- Project Manager
- Numéro de téléphone: +233243601588
- E-mail: emefa@savsign.org
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Tamale, Ghana
- Recrutement
- Kanvilli Health Center
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Contact:
- Project Manager
- Numéro de téléphone: +233243601588
- E-mail: emefa@savsign.org
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria at Recruitment:
- 18 years and older, third trimester of pregnancy, able to understand English or "Dagbani" (the local language)
Inclusion Criteria at Enrollment:
- 18 years and older, had a live birth, able to understand English or "Dagbani" (the local language)
Exclusion Criteria:
- Had a stillbirth
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Focused-PPC Group
Focused-PPC will be implemented in 12 groups (3 groups per health center), with each group having 8 postpartum women.
Each group will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year postpartum following the Ghana Health Service (GHS) postnatal care schedule.
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Individual clinical assessments and counseling for each group member will last about 15 minutes.
Then, there will be 1 hour of group time dedicated to education and support.
Each group session will be led by two trained and registered midwives who will provide both clinical care, education, and support as needed.
In addition, each group session will be supported by a project assistant.
Focused-PPC will be implemented in addition to newborn care.
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Comparateur actif: Standard PNC Group
The control group will contain parallel number of participants as the intervention group in each health center
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Women in the control group will receive standard postnatal care (PNC) currently practiced in the health centers.
This involves attending PNC visits at the health center within 14 days after birth, at 6 weeks, and monthly thereafter up to one year.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Post-Birth Warning Signs Identified Per Participant
Délai: 1 year
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Knowledge of post-birth warning signs will be assessed using a question that asks participants to identify (check all that apply) warning signs of complications. Response options will include nine post-birth warning signs. Each item will be recorded as dichotomous, with a value of 1 assigned if the woman identified the warning sign and 0 if she did not. The total knowledge score will be the sum of these dichotomous items. The mean knowledge score will be calculated as the total knowledge score divided by 9 and reflect the percentage of warning signs known. We will model and test the between treatment and control group's knowledge of post-birth warning signs at each timepoint and between timepoints will be assessed using a repeated measure multivariate analysis of variance (MANOVA) with a time and treatment interaction will be run as the primary analysis controlling for baseline demographic variables. |
1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Postpartum Health Behaviors Practiced
Délai: 1 year
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Postpartum Health Behaviors will be assessed using a questionnaire.
The questionnaire will identify which PNC visits the participant attended, how participants feed their baby, how often the participant adheres to the 4-star diet, feelings on getting pregnant within 6 months of giving birth, plans on getting pregnant within 6 months of giving birth, and intentions on getting pregnant within 6 months of giving birth.
The researchers expect health behaviors to be different between the Focused-PPC and control groups.
All health behavior questions are all categorical and will be aggregated using latent class analysis.
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1 year
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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postpartum health status
Délai: 1 year
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overall health and mental health
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1 year
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Overall Satisfaction of Focused-PPC Sessions
Délai: 1 year
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Using a questionnaire, we will record how satisfied participants were with the education received during the Focused-PPC sessions, the clinical care received during the Focused-PPC sessions, whether length of sessions was satisfactory or disliked, whether length of sessions was satisfactory or disliked, whether information provided was satisfactory or disliked, whether peer support was satisfactory or disliked, and whether the group format was liked by participants.
These measures are all categorical and will be aggregated using factor analysis.
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1 year
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yenupini J Adams, PhD, BSN, University of Notre Dame
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 21-06-6662
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Soins post-partum
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Parc de Salut MarHospital del Mar Research Institute (IMIM); COIB, Col·legi d'Infermers i infermeres... et autres collaborateursComplétéRelations infirmières-médecins | Stress professionnel | Champ d'application de l'infirmière praticienne | Environnement de travail des infirmières | Programme Committed Centers With Excellence in Care (CCEC®) | Attitudes des infirmières en matière de pratique fondée sur des données probantesEspagne
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Hannah Palma CarlosComplétéDépression postpartumRoyaume-Uni
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University of CalgaryAlberta Health servicesComplétéDépression postpartumCanada
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Centre Hospitalier Universitaire de BesanconInconnueDépression postpartumFrance
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HaEmek Medical Center, IsraelInconnue
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Xinqiao Hospital of ChongqingComplété
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NMP Medical Research InstituteWarwick Research Services; Mothers Touch Foundation, IndiaComplétéQualité de vie | Dépression postpartumInde
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Seoul National University Bundang HospitalRecrutementDépression postpartumCorée, République de
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Verinder SharmaPas encore de recrutementDépression postpartumCanada
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University of CoimbraFundação para a Ciência e a TecnologiaRecrutementDépression postpartumLe Portugal
Essais cliniques sur Focused-PPC Care
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Norwegian Center for Violence and Traumatic Stress...King's College London; University of Oslo; Ministry of Health and Care Services...RecrutementSSPT | Qualité de vie | Troubles du sommeil | Symptômes dépressifsNorvège
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C. R. BardComplétéMaladies artérielles occlusives | Maladie artérielle périphérique | Maladies vasculaires périphériquesÉtats-Unis
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University of California, San DiegoNational Institute on Aging (NIA)ComplétéLa maladie de Parkinson | Troubles respiratoires du sommeilÉtats-Unis
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Vanderbilt UniversityNational Institute of Neurological Disorders and Stroke (NINDS)ComplétéÉpilepsie | Apnée obstructive du sommeil | Apnée du sommeilÉtats-Unis
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Sheba Medical CenterRecrutement
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Woolcock Institute of Medical ResearchPas encore de recrutementApnée obstructive du sommeil | Pré-diabèteAustralie
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Silke Wiegand-Grefe, Prof. Dr.Charite University, Berlin, Germany; Hannover Medical School; University Hospital... et autres collaborateursActif, ne recrute pasMaladies raresAllemagne
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Peking University People's HospitalPas encore de recrutement
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University Health Network, TorontoSunnybrook Health Sciences CentreRecrutementTroubles du sommeil | Apnée du sommeil | Blessures à la moelle épinière | Maladie de la colonne vertébrale | Trouble respiratoire pendant le sommeilCanada
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Bambino Gesù Hospital and Research InstituteRecrutementDyscalculie développementaleItalie