Mobile Health Support Before Oocyte Pick-Up in Infertile Women (OPUCARE)
Effect of a Structured Mobile Health Application on Medication Adherence and Quality of Life in Infertile Women Before Oocyte Pick-Up
This study aims to evaluate the effect of the OPUCARE system, a structured mobile health application used before oocyte pick-up (OPU), on medication adherence and quality of life in infertile women. The study will also examine the possible effect of the intervention on state anxiety.
Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive routine clinical care plus the OPUCARE system. The control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.
The intervention period will last approximately 2 weeks, from the start of medication treatment until oocyte pick-up. Medication adherence, quality of life, and state anxiety will be assessed before and after the intervention period.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study is planned as a prospective, two-arm, randomized controlled trial to evaluate the clinical effectiveness of the OPUCARE system in infertile women during the period before oocyte pick-up (OPU). The study is based on a quantitative research approach and will use a pretest-posttest control group design.
The study population will consist of infertile women scheduled for OPU at a university hospital infertility clinic in Istanbul, Turkey. The sample size was determined by power analysis. According to the analysis performed using G*Power 3.1.9.7, at least 27 participants are required in each group. Considering possible attrition, 30 participants will be recruited for each group, for a total sample size of 60 participants.
Eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to the intervention group or the control group using a computer-generated randomization list prepared in advance. Because of the nature of the intervention, blinding of participants and implementers will not be possible. To reduce bias, data collection time points will be standardized, the same measurement tools will be applied to both groups in the same order, and analyses will be conducted according to a predefined statistical plan.
Participants in the intervention group will receive routine clinical care plus the OPUCARE system. Participants in the control group will receive routine clinical care and standard written and verbal information provided by the clinic, without mobile health application support.
The OPUCARE system consists of two components: a patient-facing mobile support application and a clinic panel that allows healthcare professionals to monitor coded patient data. The patient application includes medication reminders, treatment process information, administration guidance, side effect management content, motivational messages, and an OPU countdown. The clinic panel enables secure monitoring of coded data such as medication adherence percentage, daily log-in frequency, module completion rates, and basic follow-up indicators.
The intervention period will last approximately 2 weeks, from the start of medication treatment until OPU. The primary outcomes of the study are medication adherence and fertility-related quality of life. State anxiety will be evaluated as a secondary psychosocial outcome. In addition, system usage indicators and user satisfaction with OPUCARE will be assessed in the intervention group.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Emine Avcu, Lecturer, PhD student
- Numero di telefono: +90 507 215 35 09
- Email: emine.avcu@stu.istinye.edu.tr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Female participants aged 18 years and older
- Diagnosed with primary infertility
- Scheduled to undergo oocyte pick-up (OPU) for the first time
- Newly starting medication treatment during the period before OPU
- Own a smartphone and are able to use basic mobile applications
- Willing to participate in the study and provide written informed consent
Exclusion Criteria:
- Diagnosis of secondary infertility
- Presence of a serious chronic disease that may significantly affect medication adherence and/or quality of life
- Presence of an active serious psychiatric disorder
- Cognitive or physical limitation that prevents use of the mobile application
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Routine clinical care plus OPUCARE
Participants will receive routine clinical care and standard written and verbal information provided by the clinic, plus the OPUCARE system during the period before oocyte pick-up (OPU).
|
OPUCARE is a structured mobile health support system consisting of a patient-facing mobile application and a clinic panel for coded patient monitoring.
The patient application includes medication reminders, treatment process information, medication administration guidance, side effect management content, motivational messages, and an oocyte pick-up (OPU) countdown.
Routine clinical care includes the standard counseling and written and verbal medication information routinely provided by the infertility clinic before oocyte pick-up (OPU).
No mobile health application support will be provided as part of routine clinical care.
|
|
Comparatore attivo: Routine clinical care
Participants will receive routine clinical care and standard written and verbal information provided by the clinic during the period before oocyte pick-up (OPU), without mobile health application support.
|
Routine clinical care includes the standard counseling and written and verbal medication information routinely provided by the infertility clinic before oocyte pick-up (OPU).
No mobile health application support will be provided as part of routine clinical care.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in medication adherence score
Lasso di tempo: Baseline and day 14
|
Medication adherence will be assessed using the Medication Adherence Report Scale.
The scale consists of 5 items scored on a 5-point Likert scale.
Total scores range from 5 to 25, with higher scores indicating better medication adherence.
The change in score between baseline and day 14 will be evaluated.
|
Baseline and day 14
|
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Change in fertility-related quality of life score
Lasso di tempo: Baseline and day 14
|
Fertility-related quality of life will be assessed using the Fertility Quality of Life Questionnaire.
The questionnaire evaluates the impact of infertility and fertility treatment on quality of life.
Scores are transformed to a 0 to 100 scale, with higher scores indicating better fertility-related quality of life.
The change in score between baseline and day 14 will be evaluated.
|
Baseline and day 14
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in state anxiety score
Lasso di tempo: Baseline and day 14
|
State anxiety will be assessed using the State-Trait Anxiety Inventory-State form.
The scale consists of 20 items scored on a 4-point Likert scale.
Total scores range from 20 to 80, with higher scores indicating worse state anxiety.
The change in score between baseline and day 14 will be evaluated.
|
Baseline and day 14
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Daily log-in frequency
Lasso di tempo: Day 1 through day 14
|
Daily log-in frequency will be collected in the intervention group through OPUCARE system logs.
The total number of participant log-ins recorded during the intervention period will be evaluated.
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Day 1 through day 14
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Module completion rate
Lasso di tempo: Day 1 through day 14
|
Module completion rate will be collected in the intervention group through OPUCARE system logs.
The percentage of completed educational and support modules during the intervention period will be evaluated.
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Day 1 through day 14
|
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Medication confirmation percentage
Lasso di tempo: Day 1 through day 14
|
Medication confirmation percentage will be collected in the intervention group through OPUCARE system logs.
The percentage of medication reminders confirmed by participants during the intervention period will be evaluated.
|
Day 1 through day 14
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Emine Avcu, Lecturer, PhD student, Istinye University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Disordini mentali
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie genitali, femmina
- Infertilità
- Comportamento
- Aderenza e conformità al trattamento
- Comportamento sanitario
- Conformità del paziente
- Accettazione dell'assistenza sanitaria da parte del paziente
- Disturbi d'ansia
- Infertilità, femmina
- Aderenza ai farmaci
Altri numeri di identificazione dello studio
- OPUCARE-2026-01
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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