NCT01481064

Brief Summary

The purpose of this study is to evaluate the effects and costs of a multifaceted approach on the patient-centredness of fertility care and the quality of life of fertility patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
870

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 23, 2013

Status Verified

July 1, 2013

Enrollment Period

2.3 years

First QC Date

November 21, 2011

Last Update Submit

July 22, 2013

Conditions

Patient CentrednessQuality of LifeRisk Factors for Emotional Maladjustment

Keywords

Patient centrednessQuality of lifeMultifaceted approachFertility care

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the level of patient-centredness at one year

    Main outcome measure will be the difference in the level of patient-centredness after the multifaceted approach between control and intervention group. The level of patient-centredness will be determined by a patients' questionnaire (PCQ-Infertility).

    one year

Secondary Outcomes (3)

  • Change from baseline in patients' quality of life at one year

    1 year

  • Change from baseline in risk factors of emotional maladjustment at one year

    1 year

  • Cost-effectiveness

    one year

Study Arms (2)

Multifaceted approach

ACTIVE COMPARATOR

After baseline measurement a multifaceted approach will start for 1 year, including audit and feedback, an educational outreach visit, and patient-mediated interventions.

Behavioral: Multifaceted approach

Usual care

NO INTERVENTION

After baseline measurement no intervention will occur in these hospitals.

Interventions

Multifaceted approachBEHAVIORAL

Audit and feedback, educational outreach visits, and patient-mediated interventions.

Multifaceted approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing MAR-treatment (ovulation induction, intra-uterine inseminations, in vitro fertilization, or intra-cytoplasmic sperm injection).

You may not qualify if:

  • Pregnant couples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Radboud Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (2)

  • Huppelschoten AG, Nelen WL, Westert GP, van Golde RJ, Adang EM, Kremer JA. Improving patient-centredness in partnership with female patients: a cluster RCT in fertility care. Hum Reprod. 2015 May;30(5):1137-45. doi: 10.1093/humrep/dev041. Epub 2015 Mar 6.

    PMID: 25750102DERIVED

  • Huppelschoten AG, van Duijnhoven NT, Hermens RP, Verhaak C, Kremer JA, Nelen WL. Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial. Trials. 2012 Sep 24;13:175. doi: 10.1186/1745-6215-13-175.

    PMID: 23006997DERIVED

Study Officials

  • J Kremer, PhD

    Radboud University Medical Center

    STUDY CHAIR

  • W Nelen, PhD

    Radboud University Medical Center

    STUDY DIRECTOR

  • A Huppelschoten, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 29, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2013

Study Completion

October 1, 2013

Last Updated

July 23, 2013

Record last verified: 2013-07

Locations

NL(1)