miPlan: A Trial of miPlan Intervention vs. Standard of Care
24. august 2016 opdateret af: University of Chicago
miPlan: A Randomized Controlled Trial of miPlan Intervention vs. Standard of Care
Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit.
The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care.
The aim of this study is to understand miPlan's impact.
The primary outcome is LARC uptake at clinic discharge.
The secondary outcomes are contraceptive use at discharge, self-efficacy and decisional balance for highly effective contraception post-app use, contraceptive satisfaction, and intention to continue method use.
The research will consist of baseline activities as well as a three-month follow-up call.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")-miPlan-to be used in the clinic waiting room prior to a contraceptive visit.
The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care contraceptive counseling.
The aim of this study is to understand miPlan's impact in terms of contraceptive knowledge, intentions and behaviors.
The primary outcome is LARC uptake, which will be measured via chart review at clinic discharge, i.e. immediately following a patient's family planning visit.
The secondary outcomes are contraceptive use at discharge (measured via chart review immediately following patient's family planning visit), self-efficacy and decisional balance (both measured via adapted validated scales for each) for highly effective contraception post-app use (measured immediately following intervention and prior to contraceptive counseling session), contraceptive satisfaction (measured at 3 months post baseline), and intention to continue method use (measured at 3 months post baseline).
The research will consist of baseline activities as well as a three-month follow-up call.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
225
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60636
- Planned Parenthood Illinois, Englewood Health Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år til 29 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- African American or Latina female and sexually active with a male partner(s) within the past 6 months,
- age 15 to 29 years
- present for contraception initiation
- English speaking
Exclusion Criteria:
- not currently pregnant or intending pregnancy within the next 6 months
- and not currently using LARC
- not highly intending LARC at enrollment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention
After completing baseline the baseline questionnaire, women randomized to the intervention group will receive an iPad, along with a brief tutorial on iPad navigation, and use the miPlan app for up to 15 minutes.
They will complete a post-intervention survey before proceeding to standard of care contraceptive counseling.
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miPlan mobile contraceptive counseling waiting room app intervention
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Ingen indgriben: Control
After completing baseline the baseline questionnaire, women randomized to the control arm will proceed to standard of care contraceptive counseling.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
LARC uptake
Tidsramme: at time of intervention (baseline (0 weeks)
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uptake of the implant or IUD at time of intervention (measured via contraceptive method choice and delivery by checkbox)
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at time of intervention (baseline (0 weeks)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
contraceptive use
Tidsramme: at time of intervention (baseline (0 weeks))
|
use of contraceptive methods at time of intervention (measured via contraceptive method choice and delivery by checkbox)
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at time of intervention (baseline (0 weeks))
|
|
change in self-efficacy for contraception at 12 weeks
Tidsramme: baseline (0 weeks) and 12 weeks
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change in self efficacy for contraceptive method use (measured via validated 5-item attitudinal scale by Galavotti et al 1995) from baseline to 12 weeks
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baseline (0 weeks) and 12 weeks
|
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change in decisional balance for highly effective methods at 12 weeks
Tidsramme: baseline (0 weeks) and 12 weeks
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change in decisional balance for highly effective methods (measured via validated 10-item attitudinal scale by Galavotti et al 1995) from baseline to 12 weeks
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baseline (0 weeks) and 12 weeks
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contraceptive satisfaction
Tidsramme: 12 weeks post-enrollment
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satisfaction with contraceptive method choice (measured by 4-point Likert scale)
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12 weeks post-enrollment
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intention to continue method use
Tidsramme: 12 weeks post enrollment
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intention to continue contraceptive method use (measured dichotomously)
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12 weeks post enrollment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Melissa Gilliam, MD, MPH, University of Chicago, Dept. of OBGYN
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2015
Primær færdiggørelse (Faktiske)
1. juni 2016
Studieafslutning (Faktiske)
1. august 2016
Datoer for studieregistrering
Først indsendt
16. februar 2015
Først indsendt, der opfyldte QC-kriterier
17. marts 2015
Først opslået (Skøn)
24. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 14-0599
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .