scholarly journals Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial

2019 ◽  
Author(s):  
Mie de Wolff ◽  
Marianne Johansen ◽  
Anne Schoedt Ersboell ◽  
Susanne Rosthoej ◽  
Anne Brunsgaard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Chronic Diseases ◽  
Maternity Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Well Being ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Pregnancy And Postpartum

Abstract Background and objectives: The number of women of childbearing age with chronic diseases is rising. Evidence has shown that obstetric complications and poor psychological well-being are more prevalent among this group, in addition to these women reporting experiences of less than satisfactory care. More research is needed to investigate how to best meet the special needs of this group during pregnancy and postpartum. Previous research has shown that care coordination, continuity of care, woman-centered care and specialized maternity care interventions delivered to women with high-risk pregnancies can improve patient-reported outcomes, pregnancy outcomes, and be cost-effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard care for pregnant women with chronic diseases. Methods/design: This two-arm parallel group RCT study will be conducted from October 2018 – June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: 1. Coordinated and individualized care, 2. Additional ante- and postpartum consultations, and 3. Specialized midwives. The primary outcome is length of hospital stay (LOS) during pregnancy and postpartum period and secondary outcomes are: psychological well-being (the five-item World Health Organization Well-being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (the 12-Item Short Form Survey), patient satisfaction (The Pregnancy and Childbirth Questionnaire), number of antenatal contacts, and pregnancy and delivery outcomes. Data is collected via patient-administered questionnaires and medical records. Discussion: This trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra- and postpartum care for women with chronic disease is founded.

scholarly journals Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial

2018 ◽  
Author(s):  
Mie de Wolff ◽  
Marianne Johansen ◽  
Anne Schoedt Ersboell ◽  
Susanne Rosthoej ◽  
Anne Brunsgaard ◽  
...  
Keyword(s):  
Chronic Disease ◽  
Pregnant Women ◽  
Chronic Diseases ◽  
Maternity Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Well Being ◽  
Psychological Well Being ◽  
Randomized Controlled ◽  
Care Intervention

Abstract Background: The number of women of childbearing age with chronic diseases is rising. The risk of obstetric complications and poor psychological well-being is higher among these women, and research is needed to investigate how to meet the obstetric and psychological needs of this group during pregnancy and in the postpartum period. Previous research has shown that care coordination, continuity of care, woman-centered care and specialized maternity care interventions delivered to women with high-risk pregnancies can improve patient-reported outcomes, pregnancy outcomes, and be cost-effective. However, no previous trials have examined the efficacy and cost-effectiveness of such interventions among pregnant women with chronic diseases. This paper describes the protocol of a randomized controlled trial (RCT) of a midwife-coordinated, individualized and specialized maternity care intervention (ChroPreg) as an add-on to standard care for pregnant women with chronic diseases. Methods: This two-arm parallel group RCT study will be conducted from October 2018 – June 2020 at the Department of Obstetrics, Copenhagen University Hospital, Rigshospitalet, Denmark. Pregnant women with chronic diseases are invited to participate; 274 women will be randomized and allocated 1:1 to the ChroPreg intervention plus standard care or standard care alone. The ChroPreg intervention consists of three main components: 1. Coordinated and individualized care, 2. Additional ante- and postpartum consultations, and 3. Specialized midwives. The primary outcome is length of hospital stay (LOS) during pregnancy and in the postpartum period and secondary outcomes are: psychological well-being (the five-item World Health Organization Well-being Index, Edinburgh Postnatal Depression Scale, Cambridge Worry Scale), health-related quality of life (the 12-Item Short Form Survey), patient satisfaction (The Pregnancy and Childbirth Questionnaire), and number of antenatal visits. Explorative outcomes will be pregnancy and delivery outcomes. Data is collected via patient-administered questionnaires and from medical records. Discussion: This trial is anticipated to contribute to the field of knowledge on which planning of improved antenatal, intra- and postpartum care for women with chronic disease is founded. Trial Registration: ClinicalTrials.gov: NCT03511508. Registered June 22, 2018 Keywords: Pregnancy, chronic disease, midwifery, maternity care, antenatal care, psychological well-being, complex intervention

scholarly journals Effects of a Midwife-Coordinated Maternity Care Intervention (ChroPreg) vs. Standard Care in Pregnant Women with Chronic Medical Conditions: Results from a Randomized Controlled Trial

2021 ◽  
Vol 18 (15) ◽  
pp. 7875
Author(s):  
Mie G. de Wolff ◽  
Julie Midtgaard ◽  
Marianne Johansen ◽  
Ane L. Rom ◽  
Susanne Rosthøj ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Maternity Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Chronic Medical Conditions ◽  
Medical Conditions ◽  
Randomized Controlled ◽  
Individualized Care ◽  
Care Intervention

The proportion of childbearing women with pre-existing chronic medical conditions (CMC) is rising. In a randomized controlled trial, we aimed to evaluate the effects of a midwife-coordinated maternity care intervention (ChroPreg) in pregnant women with CMC. The intervention consisted of three main components: (1) Midwife-coordinated and individualized care, (2) Additional ante-and postpartum consultations, and (3) Specialized known midwives. The primary outcome was the total length of hospital stay (LOS). Secondary outcomes were patient-reported outcomes measuring psychological well-being and satisfaction with maternity care, health utilization, and maternal and infant outcomes. A total of 362 women were randomized to the ChroPreg intervention (n = 131) or Standard Care (n = 131). No differences in LOS were found between groups (median 3.0 days, ChroPreg group 0.1% lower LOS, 95% CI −7.8 to 7%, p = 0.97). Women in the ChroPreg group reported being more satisfied with maternity care measured by the Pregnancy and Childbirth Questionnaire (PCQ) compared with the Standard Care group (mean PCQ 104.5 vs. 98.2, mean difference 6.3, 95% CI 3.0–10.0, p < 0.0001). In conclusion, the ChroPreg intervention did not reduce LOS. However, women in the ChroPreg group were more satisfied with maternity care.

scholarly journals The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Elizabeth Mayfield Arnold ◽  
Dallas Swendeman ◽  
Danielle Harris ◽  
Jasmine Fournier ◽  
Leslie Kozina ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Youth Living With Hiv ◽  
Living With Hiv

BACKGROUND Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life. OBJECTIVE This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected). METHODS YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms. RESULTS Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020. CONCLUSIONS This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life. CLINICALTRIAL ClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10791

scholarly journals Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: Randomized Controlled Trial

10.2196/10420 ◽  
2018 ◽  
Vol 5 (3) ◽  
pp. e10420 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Standard Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Over Time

Background Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth should be handled in clinical care. Objective This randomized controlled trial aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care on the levels of fear of birth in a sample of pregnant women reporting fear of birth. Methods This nonblinded, multicenter randomized controlled trial with a parallel design was conducted at three study centers (hospitals) in Sweden. Recruitment commenced at the ultrasound screening examination during gestational weeks 17-20. The therapist-guided ICBT intervention was inspired by the Unified protocol for transdiagnostic treatment of emotional disorders and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their fear of birth and find new ways of coping with difficult thoughts and emotions. Standard care was offered in the three different study regions. The primary outcome was self-assessed levels of fear of birth, measured using the Fear of Birth Scale. Results We included 258 pregnant women reporting clinically significant levels of fear of birth (guided ICBT group, 127; standard care group, 131). Of the 127 women randomized to the guided ICBT group, 103 (81%) commenced treatment, 60 (47%) moved on to the second module, and only 13 (10%) finished ≥4 modules. The levels of fear of birth did not differ between the intervention groups postintervention. At 1-year postpartum follow-up, participants in the guided ICBT group exhibited significantly lower levels of fear of birth (U=3674.00, z=−1.97, P=.049, Cohen d=0.28, 95% CI –0.01 to 0.57). Using the linear mixed models analysis, an overall decrease in the levels of fear of birth over time was found (P≤ .001), along with a significant interaction between time and intervention, showing a larger reduction in fear of birth in the guided ICBT group over time (F1,192.538=4.96, P=.03). Conclusions Fear of birth decreased over time in both intervention groups; while the decrease was slightly larger in the guided ICBT group, the main effect of time alone, regardless of treatment allocation, was most evident. Poor treatment adherence to guided ICBT implies low feasibility and acceptance of this treatment. Trial Registration ClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat)

scholarly journals A Quasi-Randomized Controlled Trial of the I-PLAN Intervention to Promote Hearing Aid Use Among First-Time Adult Hearing Aid Users

2021 ◽  
Vol 25 ◽  
pp. 233121652096947
Author(s):  
Afzarini H. Ismail ◽  
Kevin J. Munro ◽  
Christopher J. Armitage ◽  
Antonia Marsden ◽  
Piers D. Dawes
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Aids ◽  
Standard Care ◽  
Hearing Aid ◽  
Controlled Trial ◽  
Well Being ◽  
Randomized Controlled ◽  
Hearing Aid Use ◽  
Hearing Difficulty ◽  
First Time

Suboptimal hearing aid use negatively impacts health and well-being. The aim of this study was to conduct a controlled trial of a behavior change intervention to promote hearing aid use. This study was a quasi-randomized controlled trial with two arms. A total of 160 first-time hearing aid users were recruited at their hearing aid fitting appointments. The control arm received standard care. In addition to standard care, the intervention arm received I-PLAN, which comprised (a) information about the consequences of hearing aid use/nonuse, (b) reminder prompt to use the hearing aids, and (c) an action plan. The primary outcome, measured at 6 weeks, was self-reported proportion of time the hearing aid was used in situations that caused hearing difficulty. Secondary outcomes were data-logged hearing aid use, self-reported hearing aid benefit, self-regulation, and habit formation. The results showed that the proportion of time the hearing aids were used in situations that caused hearing difficulty was similar in both groups. There were no statistically significant differences between groups in any outcome measure including data-logged hearing aid use. The relatively high levels of hearing aid use across research participants may have limited the potential for the intervention to impact on hearing aid use. Although the intervention materials proved acceptable and deliverable, future intervention trials should target suboptimal hearing aid users.

scholarly journals Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: A Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Elisabet Rondung ◽  
Elin Ternström ◽  
Ingegerd Hildingsson ◽  
Helen M Haines ◽  
Örjan Sundin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Pregnant Women ◽  
Standard Care ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Over Time

BACKGROUND Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth (FOB) should be handled in clinical care. OBJECTIVE This randomized controlled trial (RCT) aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care (SC) on the levels of FOB in a sample of pregnant women reporting FOB. METHODS This nonblinded, multicenter RCT with a parallel design was conducted at three study centers (hospitals) in Sweden. Recruitment commenced at the ultrasound screening examination during gestational weeks 17-20. The therapist-guided ICBT intervention was inspired by the Unified protocol for transdiagnostic treatment of emotional disorders (UP) and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their FOB and find new ways of coping with difficult thoughts and emotions. SC was offered in the three different study regions. The primary outcome was self-assessed levels of FOB, measured using the Fear of Birth Scale (FOBS). RESULTS We included 258 pregnant women reporting clinically significant levels of FOB (guided ICBT group, 127; SC group, 131). Of the 127 women randomized to the guided ICBT group, 103 (81%) commenced treatment, 60 (47%) moved on to the second module, and only 13 (10%) finished ≥4 modules. The levels of FOB did not differ between the intervention groups postintervention. At 1-year postpartum follow-up, participants in the guided ICBT group exhibited significantly lower levels of FOB (U=3674.00, z=−1.97, P=.049, Cohen d=0.28, 95% CI –0.01 to 0.57). Using the linear mixed models analysis, an overall decrease in the levels of FOB over time was found (P=<.001), along with a significant interaction between time and intervention, showing a larger reduction in FOB in the guided ICBT group over time (F1,192.538=4.96, P=.03). CONCLUSIONS FOB decreased over time in both intervention groups; while the decrease was slightly larger in the guided ICBT group, the main effect of time alone, regardless of treatment allocation, was most evident. Poor treatment adherence to guided ICBT implies low feasibility and acceptance of this treatment. CLINICALTRIAL ClinicalTrials.gov NCT02306434; https://clinicaltrials.gov/ct2/show/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat)

Exercise Throughout Pregnancy Does not Cause Preterm Delivery: A Randomized, Controlled Trial

2014 ◽  
Vol 11 (5) ◽  
pp. 1012-1017 ◽  
Author(s):  
Ruben Barakat ◽  
Mireia Pelaez ◽  
Rocio Montejo ◽  
Ignacio Refoyo ◽  
Javier Coteron
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Preterm Delivery ◽  
Gestational Age ◽  
Controlled Trial ◽  
Exercise Program ◽  
Well Being ◽  
Exercise Group ◽  
Control Group ◽  
Randomized Controlled

Background:In spite of an extensive knowledge of the physiologic features of exercise during pregnancy, we still lack a comprehensive understanding of the effects of different types, intensities and duration of exercise throughout pregnancy on maternal and fetal well being. The aim of the current study was to examine the influence of an aerobic exercise program throughout pregnancy on gestational age at the moment of delivery.Methods:This study was a randomized controlled trial. Three hundred and twenty Caucasian (Spanish) healthy pregnant women with singleton gestation were randomly assigned to either an exercise (n = 160) or a control (n = 160) group. Gestational age (weeks) and other outcomes were measured. The exercise program included 85 sessions (general fitness class, 3 times/week, 55–60 min/session from weeks 8–10 to weeks 38–39 of pregnancy).Results:Two hundred and ninety women were analyzed (exercise group EG, n = 138, control group CG, n = 152). The mean gestational age did not differ between groups (EG= 39.7± 1.3 vs CG= 39.6 ± 1.1 weeks, P = .81). Relative to preterm deliveries in EG we found 6 (4.3%) and 11 (7.2%) in CG, (P = .73).Conclusions:A supervised program of moderate exercise performed throughout pregnancy is not a risk of preterm delivery for healthy pregnant women.

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