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Group Based Care Versus Individual Care

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT01224275
Collaborator
(none)
1,150
Enrollment
1
Location
2
Arms
81
Duration (Months)
14.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: group based care
 N/A

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 Design

Study Type:
Interventional
Actual 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 :
Aug 1, 2008
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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 Names:
  • intervention including midwifes in the care.

    		•
    No Intervention: Individual antenaal care

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

    Outcome Measures

    Primary Outcome Measures

    1. Group based antenatal care versus Individual care- parent´s satisfaction with care [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Must be able to Speak Swedish
    Exclusion Criteria:
    • Non speaking Swedish

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karolinska Institut-Woman and childrens health Stockholm Sweden 17177

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ewa Andersson, KBH, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT01224275
    Other Study ID Numbers:
    • 2007/553
    First Posted:
    Oct 20, 2010
    Last Update Posted:
    Oct 29, 2020
    Last Verified:
    Oct 1, 2020
    Keywords provided by Ewa Andersson, KBH, Karolinska Institutet
    group based care
    antenatal care
    parents satisfaction
    Antenatal care´s organization and patient satisfaction

    Study Results

    No Results Posted as of Oct 29, 2020