Dataset Information

Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial.

ABSTRACT:

Objective

Describe the effects of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial.

Study design

We assessed the number of eligible infants approached and consented for enrollment over five separate epochs including baseline, peak pandemic, and gradual but incomplete recovery.

Result

The pandemic had a major effect on ability to approach parents for consent. Parents approached dropped from 95.4% baseline to 13.1% in the peak pandemic epoch and has not recovered to baseline even in the just-completed post-pandemic epoch (84.9%). Despite the decrease in subjects approached, there was no significant change in the overall consent rate for the study CONCLUSION: The pandemic has significantly limited ability to approach parents of eligible infants for consent, with only partial recovery. Opportunities for interactions of investigators and study coordinators with parents continue to present challenges limiting full recovery.

SUBMITTER: Abu Jawdeh EG

PROVIDER: S-EPMC9798371 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial.

Abu Jawdeh Elie G EG Hunt Carl E CE Eichenwald Eric E Corwin Michael J MJ McEntire Betty B Heeren Timothy T Crowell Lisa M LM Ikponmwonba Christine C Saroufim Ariana A Kerr Stephen S

Journal of perinatology : official journal of the California Perinatal Association 20221229 5

<h4>Objective</h4>Describe the effects of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial.<h4>Study design</h4>We assessed the number of eligible infants approached and consented for enrollment over five separate epochs including baseline, peak pandemic, and gradual but incomplete recovery.<h4>Result</h4>The pandemic had a major effect on ability to approach parents for consent. Parents approached dropped from 95.4% baseline to 13.1% in the peak pandemic ...[more]

PMID: 36581761

Similar Datasets

Project description:BackgroundSocietal measures to contain the spread of COVID-19 (eg, lockdown and contact restrictions) have been associated with decreased health and well-being. A multitude of prepandemic studies identified the beneficial effects of physical exercise on both physical and mental health.ObjectiveWe report on the feasibility of a remote physical exercise intervention and its stress-buffering potential in 2 untrained cohorts: a pre-COVID-19 cohort that completed the intervention in 2019 and a lockdown cohort that started the intervention shortly before pandemic-related restrictions were implemented.MethodsIn a randomized controlled trial, participants were assigned to either an intervention group (IG; pre-COVID-19 cohort: n=7 and lockdown cohort: n=9) or a control group (CG; pre-COVID-19 cohort: n=6 and lockdown cohort: n=6). IG participants received weekly individualized training recommendations delivered via web-based support. The intervention period was initially planned for 8 weeks, which was adhered to in the pre-COVID-19 cohort (mean 8.3, SD 0.5 weeks) but was extended to an average of 17.7 (SD 2.0) weeks in the lockdown cohort. Participants' health parameters were assessed before and after the intervention: aerobic capacity was measured as peak oxygen uptake (VO2peak) via cardiopulmonary exercise testing. Depressive symptoms were scored via the depression subscale of the Brief Symptom Inventory-18.ResultsDropout rates were low in both cohorts in the IG (pre-COVID-19 cohort: n=0, 0% and lockdown cohort: n=2, 16.7%) and the CG (pre-COVID-19 cohort: n=0, 0% and lockdown cohort: n=2, 20%). The mean adherence to the training sessions of the IG for both cohorts was 84% (pre-COVID-19 cohort: SD 5.5% and lockdown cohort: SD 11.6%). Aligned rank transform ANOVAs in the lockdown cohort indicated deterioration of VO2peak and depressive symptoms from before to after the intervention in the CG but no longitudinal changes in the IG. Analyses in the pre-COVID-19 cohort revealed significant increases in VO2peak for the IG compared to the CG (P=.04) but no intervention effects on depressive symptoms.ConclusionsWith low dropout rates and high adherence, the remote intervention was feasible for healthy adults under regular conditions and in the face of pandemic-related stressors. Moreover, our results hint at a stress-buffering effect as well as a buffering of a lockdown-induced deconditioning of remote physical exercise interventions in the pandemic scenario, which can be used in future studies to overcome equally stressful periods of life. However, due to limited statistical power, these findings should be replicated in similar scenarios.Trial registrationGerman Clinical Trials Register DRKS00018078; https://drks.de/search/en/trial/DRKS00018078.

Project description:ObjectiveTo assess the effect of a consumer-based mobile meditation application (app) on wellness in outpatient obstetric and gynecology patients during the coronavirus disease 2019 (COVID-19) pandemic.MethodsWe conducted a randomized controlled trial at a university outpatient clinic of obstetric and gynecology patients during the COVID-19 pandemic. Women were randomly assigned to the intervention group, who was prescribed a mobile meditation app for 30 days, or the control group, which received standard care. The primary outcome was self-reported perceived stress. Secondary outcomes included self-reported depression, anxiety, sleep disturbance, and satisfaction with the meditation app. A sample size of 80 participants (40 per group) was calculated to achieve 84% power to detect a 3-point difference in the primary outcome.ResultsFrom April to May 2020, 101 women were randomized in the study-50 in the meditation app group and 51 in the control group. Analysis was by intention-to-treat. Most characteristics were similar between groups. Perceived stress was significantly less in the intervention group at days 14 and 30 (mean difference 4.27, 95% CI 1.30-7.24, P=.005, d=0.69 and mean difference 4.28, 95% CI 1.68-6.88, P=.002, d=0.69, respectively). Self-reported depression and anxiety were significantly less in the intervention group at days 14 and 30 (depression: P=.002 and P=.04; anxiety: P=.01, and P=.04, respectively). Sleep disturbance was significantly less in the intervention group at days 14 and 30 (P=.001 and P=.02, respectively). More than 80% of those in the intervention group reported high satisfaction with the meditation app, and 93% reported that mindfulness meditation improved their stress.ConclusionOutpatient obstetric and gynecology patients who used the prescribed consumer-based mobile meditation app during the COVID-19 pandemic had significant reductions in perceived stress, depression, anxiety, and sleep disturbance compared with standard care.Clinical trial registrationClinicalTrials.gov, NCT04329533.

Dataset Information

Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial.

Objective

Study design

Result

Publications

Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets