Group Based Care Versus Individual Care

NCT ID: NCT01224275

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2015-05-31

Brief 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).

Detailed 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.

Conditions

Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group antenatal care

The first arm is midwife which allocated to group based antenatal care. They have education in this model of care and follow up meeting to secure the intervention

Group Type: EXPERIMENTAL

group based care

Intervention Type: OTHER

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

Individual antenaal care

the second arm include midwife which allocated to traditional care as control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

group based care

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

Intervention Type: OTHER

Other Intervention Names

intervention including midwifes in the care.

Eligibility Criteria

Inclusion Criteria

• Must be able to Speak Swedish

Exclusion Criteria

• Non speaking Swedish

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Ewa Andersson

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva andersson, Dr

Role: PRINCIPAL_INVESTIGATOR

eva andersson

Locations

Karolinska Institut-Woman and childrens health

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2007/553

Identifier Type: -

Identifier Source: org_study_id