Patient SatisfactionGBACNCT01224275
Group Based Care Versus Individual Care
A study testing group based care in people with Patient Satisfaction, run by Karolinska Institutet at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- group based care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2008to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be able to Speak Swedish
Who cannot join
- Non speaking Swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Group Based Care Versus Individual Care- Effects on Parents Satisfaction and Health
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).
Read the 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
- Being tested
- group based care
- Keywords
- group based care, antenatal care, parents satisfaction, Antenatal care´s organization and patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group based careOther
Also called intervention including midwifes in the care.
Midwives is randomized and allocated to group based antenatal care. The midwives have a manual for the model of care.
| Study group | Role | What they receive |
|---|---|---|
| Group antenatal care | Experimental | 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 Receives: Other: group based care |
| Individual antenaal care | No intervention | the second arm include midwife which allocated to traditional care as control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 years
Secondary outcomes (2)
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)
Measured: 4 years
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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startAug 2008
- Primary completionJun 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewa Andersson, Karolinska Institutet
- Investigators
- Eva andersson, Dr, Principal investigator, eva andersson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224275
- Sponsor's protocol ID
- 2007/553
- Acronym
- GBAC
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2010
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Based Care Versus Individual Care- Effects on Parents Satisfaction and Health
- ClinicalTrials.gov ID
- NCT01224275
- Acronym / sponsor ID
- GBAC / 2007/553
- Conditions
- Patient Satisfaction
- Keywords
- group based care, antenatal care, parents satisfaction, Antenatal care´s organization and patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group antenatal care | Experimental | Other: group based careThe 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 |
| Individual antenaal care | No intervention | –the second arm include midwife which allocated to traditional care as control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must be able to Speak Swedish
Key exclusion criteria (1 listed)
- Non speaking Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group based careAlso: intervention including midwifes in the care.Midwives is randomized and allocated to group based antenatal care. The midwives have a manual for the model of care. | Other | Group antenatal care |
Primary outcome
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
2 secondary outcomes
socialization with other parents
Time frame: 4 years
Self reported health effect on mother and child
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva andersson, Dr principal investigator
eva andersson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group based care in people with Patient Satisfaction, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group based antenatal care versus Individual care- parent´s satisfaction with care (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.