Group Based Care Versus Individual Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01224275
First received: October 19, 2010
Last updated: June 24, 2011
Last verified: September 2008
  Purpose

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 Intervention
Patient Satisfaction
Other: group based care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Group Based Care Versus Individual Care- Effects on Parents Satisfaction and Health

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Group based antenatal care versus Individual care- parent´s satisfaction with care [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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:
  • socialization with other parents [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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)

  • Self reported health effect on mother and child [ Time Frame: 6 years ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 1150
Study Start Date: August 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be able to Speak Swedish

Exclusion Criteria:

  • Non speaking Swedish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224275

Contacts
Contact: Ewa Andersson, PHD student ewa.andersson@ki.se

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

No publications provided

Responsible Party: Ewa Andersson/reg.Midwife, Karolinska Institut, KBH, Sweden
ClinicalTrials.gov Identifier: NCT01224275     History of Changes
Other Study ID Numbers: 2007/553
Study First Received: October 19, 2010
Last Updated: June 24, 2011
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014