Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana (Focused-PPC)
2022년 3월 4일 업데이트: University of Notre Dame
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.
연구 개요
상세 설명
Although the postpartum period poses substantial risks and can result in significant maternal morbidity and mortality, it receives much less attention than pregnancy and childbirth.
Appropriate postpartum care enables healthcare providers identify and treat postpartum complications promptly, offer help with a wide range of health and social needs and encourage mothers to adopt evidenced-based postpartum practices at home, since maternal self-care usually takes place at home.
In many settings in Sub-Saharan Africa, quality postpartum care, education, and support for the mother are often the missing components of postnatal care delivery, which focuses on care of the baby.
The lack of standard postpartum care for the mother contributes to maternal deaths.
There is an urgent need for an integrated postpartum care delivery model that is comprehensive and meets clinical care, education, and support needs of mothers.
Thus, the purpose of this project is to test and evaluate an innovative postpartum care, education, and support model known as Focused-PPC, in Tamale, Ghana.
The proposed project will be the first of its kind to design an integrated and comprehensive group postpartum care delivery model, focused on clinical care of the mother and baby, as well as education and peer support in Ghana.
Our model supports the clinical assessments and timeframes recommended by the World Health Organization and adopted by Ghana Health Service.
Together with my partner organization, Savana Signatures, we will develop and test Focused-PPC.
Focused-PPC will be implemented in groups in health centers in Tamale, Ghana.
Each group will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year postpartum following the Ghana health service postnatal care schedule.
Led by trained midwives in the health centers, each group session will consist of postpartum clinical assessments for mother (in addition to baby), education, and support.
Focused-PPC has the potential to change the postpartum care delivery model in Ghana and other countries in sub-Saharan Africa and beyond.
Results from this implementation will be used to further refine and scale up the Focused-PPC model of postpartum care.
연구 유형
중재적
등록 (예상)
192
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Principal Investigator
- 전화번호: +1 574 631 3224
- 이메일: yadams@nd.edu
연구 장소
-
-
-
Tamale, 가나
- 모병
- Bagabaga Health Center
-
연락하다:
- Project Manager
- 전화번호: +233243601588
- 이메일: emefa@savsign.org
-
Tamale, 가나
- 모병
- Choggu Health Center
-
연락하다:
- Project Manager
- 전화번호: +233243601588
- 이메일: emefa@savsign.org
-
Tamale, 가나
- 모병
- Kalpohin Health Center
-
연락하다:
- Project Manager
- 전화번호: +233243601588
- 이메일: emefa@savsign.org
-
Tamale, 가나
- 모병
- Kanvilli Health Center
-
연락하다:
- Project Manager
- 전화번호: +233243601588
- 이메일: emefa@savsign.org
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
|
활성 비교기: Standard PNC Group
The control group will contain parallel number of participants as the intervention group in each health center
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Post-Birth Warning Signs Identified Per Participant
기간: 1 year
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Postpartum Health Behaviors Practiced
기간: 1 year
|
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.
|
1 year
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
postpartum health status
기간: 1 year
|
overall health and mental health
|
1 year
|
|
Overall Satisfaction of Focused-PPC Sessions
기간: 1 year
|
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.
|
1 year
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Yenupini J Adams, PhD, BSN, University of Notre Dame
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 2월 26일
기본 완료 (예상)
2023년 1월 1일
연구 완료 (예상)
2023년 6월 1일
연구 등록 날짜
최초 제출
2022년 2월 10일
QC 기준을 충족하는 최초 제출
2022년 3월 4일
처음 게시됨 (실제)
2022년 3월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 3월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 3월 4일
마지막으로 확인됨
2022년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
산후조리에 대한 임상 시험
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)완전한
-
University of Kansas Medical CenterBioNexus KC; Blue KC (Blue Cross Blue Shield)완전한
-
National University of SingaporeNational University Hospital, Singapore모병
-
Istanbul University - Cerrahpasa완전한
-
University of Arizona아직 모집하지 않음그룹 1 : Carrier Care (CC) 다음 피부 대 피부 관리 (SSC)에 이어 가족 선택이 이어집니다. | 그룹 2 : 피부 대 피부 관리 (SSC) 다음 캐리어 케어 (CC)에 이어 가족 선택
-
Parc de Salut MarHospital del Mar Research Institute (IMIM); COIB, Col·legi d'Infermers i infermeres de... 그리고 다른 협력자들완전한간호사 의사 관계 | 전문적인 스트레스 | 실습 간호사의 범위 | 간호사의 작업 환경 | CCEC®(Excellence in Care) 프로그램을 갖춘 헌신적 센터 | 간호사의 증거 기반 실습 태도스페인
Focused-PPC Care에 대한 임상 시험
-
The University of Texas Medical Branch, GalvestonThe University of Texas Health Science Center, Houston완전한
-
Institute of Hematology & Blood Diseases Hospital...아직 모집하지 않음
-
Children's Hospital of Fudan University모병
-
The University of Texas Health Science Center,...National Institute on Aging (NIA)완전한
-
The Cleveland ClinicYale University; Donaghue Medical Research Foundation완전한
-
Massachusetts General HospitalNational Cancer Institute (NCI); American Cancer Society, Inc.완전한
-
Shannon E. Sauer-Zavala완전한