Group Based Care Versus Individual Care

Patient Satisfaction Clinical Trial

— GBAC  

Official title:

Group Based Care Versus Individual Care- Effects on Parents Satisfaction and Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224275
• Other study ID #: 2007/553
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: May 2015

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Study compares group based care versus individual given care-effects on patient satisfaction and health. Midwives will be randomized to either traditional antenatal care (Individual care) or group based antenatal care(intervention).

Description:

In the RCT the midwife is randomized.There are a multicenter study. Before the study started the midwives received education about the study. Then they randomized with simple randomization per site(clinics). The midwives also have follow up meeting with the research team during the recruting period. The parents are informed about the study at the booking appointment, after that they can choose if they want to participate in the study and are allocated to either intervention or control, based on the woman's date of birth. The main aim is to investigate parents' satisfaction of antenatal group based care. The RCT is based on three questionnaires which both women and their partners receive, the first at baseline before they receive different models of care, and the second questionnaire distributed four to six months after birth and the last one year after birth. Descriptive and inferential statistics will be used in the analysis.A power calculation is made and the study schould have a total number of 350 partners.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: May 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Must be able to Speak Swedish

Exclusion Criteria:

• Non speaking Swedish

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

Other:
• group based care
Midwives is randomized and allocated to group based antenatal care. The midwives have a manual for the model of care.

Locations

Country	Name	City	State
Sweden	Karolinska Institut-Woman and childrens health	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Group based antenatal care versus Individual care- parent´s satisfaction with care	Satisfaction with care and involvement of partner, three questionnaire to parents in control group and intervention group, which measure the satisfaction with care	6 years
Secondary	socialization with other parents	The study include this secondary outcome, measure with two qustionnarie four to six mounts after birth and the second qustionnarie one year after birth. The questionnare to borth group(conrtil group and intervention griup)	4 years
Secondary	Self reported health effect on mother and child	Measure the health with instrument as EPDS scale and question regarding health, parental stress and breastfeeding.Four to six months and one year after birth.; The questionnaire is sending out to both woman and partner.	6 years