Group Based Care Versus Individual Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01224275
Recruitment Status : Unknown
Verified September 2008 by Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : October 20, 2010
Last Update Posted : June 27, 2011
Information provided by:
Karolinska Institutet

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).

Condition or disease Intervention/treatment Phase
Patient Satisfaction Other: group based care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Group Based Care Versus Individual Care- Effects on Parents Satisfaction and Health
Study Start Date : August 2008
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: 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
Other: group based care
Midwives is randomized and allocated to group based antenatal care. The midwives have a manual for the model of care.
Other Name: intervention including midwifes in the care.
No Intervention: Individual antenaal care
the second arm include midwife which allocated to traditional care as control group.

Primary Outcome Measures :
  1. Group based antenatal care versus Individual care- parent´s satisfaction with care [ Time Frame: 6 years ]
    Satisfaction with care and involvement of partner, three questionnaire to parents in control group and intervention group, which measure the satisfaction with care

Secondary Outcome Measures :
  1. socialization with other parents [ Time Frame: 4 years ]
    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)

  2. Self reported health effect on mother and child [ Time Frame: 6 years ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be able to Speak Swedish

Exclusion Criteria:

  • Non speaking Swedish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01224275

Contact: Ewa Andersson, PHD student

Karolinska Institut-Woman and childrens health Recruiting
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet

Responsible Party: Ewa Andersson/reg.Midwife, Karolinska Institut, KBH, Sweden Identifier: NCT01224275     History of Changes
Other Study ID Numbers: 2007/553
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: September 2008

Keywords provided by Karolinska Institutet:
group based care
antenatal care
parents satisfaction
Antenatal care´s organization and patient satisfaction