Women’s Experiences in a Community-Based Participatory Research Randomized Controlled Trial

Abstract Background Information about and invitation to participate in a clinical trial involving an intervention during childbirth may cause fear or worry in pregnant women. The aim of this study was to describe nulliparous women’s experiences of receiving an invitation to participate in a randomized controlled trial (RCT) of lateral episiotomy versus no episiotomy in vacuum-assisted delivery (EVA trial). Methods This qualitative study was nested in the ongoing EVA trial. Data were collected through semistructured telephone interviews with 23 women regarding their experiences of the information and invitation to participate in the EVA trial. Interviews were audio-recorded and transcribed verbatim. A qualitative content analysis was used to analyse the interview contents. Results Three main experience categories were identified among the participants. “Timing of trial information and understanding” revealed that women preferred to obtain information about the trial early on during pregnancy. “Reasons to consent to or decline participation in the trial” encompassed a variety of reasons for women to consent, such as goodwill for science or personal benefits, or to decline, such as not wanting to be randomized or fear of increased risk of having a vacuum-assisted delivery. “Thoughts evoked regarding childbirth” were diverse, ranging from not being affected at all to having increased anxiety. Conclusions The women’s experience of receiving an invitation to participate in an RCT of episiotomy in vacuum-assisted delivery varied widely, from immediately giving consent without further worries to increased anxiety or declining participation. Early and personal information with time for reflection was considered most satisfactory. Trial registration ClinicalTrials.govNCT02643108. Registered on December 28, 2015. The Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women (EVA) trial was registered at www.clinicaltrials.gov.

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Community Based Non Communicable Disease Services as a Predictor of Improved Quality of Life of People Living with HIV in Uganda: A Randomized Controlled Trial

Journal of Environmental Science and Public Health ◽

10.26502/jesph.96120102 ◽

2020 ◽

Vol 04 (04) ◽

Author(s):

Christopher Ddamulira ◽

Norman Nsereko ◽

Miph Musoke ◽

Frank Pio Kiyingi

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Communicable Disease ◽

Controlled Trial ◽

People Living With Hiv ◽

Community Based ◽

Randomized Controlled ◽

Living With Hiv ◽

Non Communicable Disease

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A Community-based Addiction Rehabilitation Electronic System to Improve Recovery Outcomes in Patients with Drug Use Disorder: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.10505 ◽

2018 ◽

Author(s):

Zhe WANG ◽

Shujuan CHEN ◽

Junning CHEN ◽

Chunfeng XU ◽

Zhikang CHEN ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Drug Use ◽

Illicit Drug ◽

Service Providers ◽

Controlled Trial ◽

Electronic System ◽

Community Based ◽

Randomized Controlled ◽

Community Rehabilitation ◽

Drug Use Disorder

BACKGROUND Relapse is very common in patients with illicit drug use disorder and contributes to a series of bad consequences that substantially impact their physical and social functions. Due to the limited existence of effective addiction treatment, the majority of patients with drug use disorder could not access help when needing. Mobile health (mHealth) offers a potential solution to improving recovery outcome for patients in community. OBJECTIVE This paper is a protocol for a randomized controlled trial (RCT) of a smart phone application called community-based addiction rehabilitation electronic system (CAREs). This interactive system consists of an APP for clients and a webpage for service providers, with the aim of teaching clients craving and emergency coping skills and helping service providers to improve their work efficiency and effectiveness in community. METHODS A randomized controlled trial (RCT) will be conducted. Sixty drug illicit users who are newly ordered to undergo community rehabilitation will be recruited from the community in Shanghai. Participants will be 1:1 randomly assigned to receive integrated community rehabilitation by using CAREs or only receiving routine community rehabilitation for 6 months. Corresponding anti-drug social workers will provide service and monitor their drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at baseline and in the 6th month. The primary study outcome is the performance on illicit drug urine test which will be carried on regularly twice per week during the study period. Secondary study outcomes include longest duration of sustained abstinence, days that participants interact with anti-drug social workers, and the decrease rate of addiction-related issues severity index. RESULTS Recruitment is currently underway with the aim of recruiting 60 subjects with drug use disorder. Recruitment will continue until the end of 2018. CONCLUSIONS This is the first known trial of a smartphone-based psychotherapy program for improving recovery outcomes in illicit drug users in community. The study provides evidence for the feasibility and effectiveness of the "CAREs" system through comparing the results of the intervention group with the control group. This paper describes the design and methodology of the study. CLINICALTRIAL ClinicalTrials.gov NCT03451344, https://clinicaltrials.gov/ct2/show/NCT03451344

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Community-Based Multi-Site Randomized Controlled Trial of Behavioral Activation for Patients with Depressive Disorders

Community Mental Health Journal ◽

10.1007/s10597-021-00828-3 ◽

2021 ◽

Author(s):

Eunbyeol Lee ◽

Yeoul Han ◽

Yun Ji Cha ◽

Ji-Hye Oh ◽

Na-Ri Hwang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Depressive Disorders ◽

Behavioral Activation ◽

Controlled Trial ◽

Community Based ◽

Randomized Controlled

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Effectiveness of Yoga Lifestyle on Lipid Metabolism in a Vulnerable Population—A Community Based Multicenter Randomized Controlled Trial

Medicines ◽

10.3390/medicines8070037 ◽

2021 ◽

Vol 8 (7) ◽

pp. 37

Author(s):

Raghuram Nagarathna ◽

Saurabh Kumar ◽

Akshay Anand ◽

Ishwara N. Acharya ◽

Amit Kumar Singh ◽

...

Keyword(s):

Randomized Controlled Trial ◽

High Risk ◽

Controlled Trial ◽

Density Lipoprotein ◽

Lipid Profiles ◽

Community Based ◽

Randomized Controlled ◽

Rural And Urban ◽

Yoga Group ◽

The Impact

Background: Dyslipidemia poses a high risk for cardiovascular disease and stroke in Type 2 diabetes (T2DM). There are no studies on the impact of a validated integrated yoga lifestyle protocol on lipid profiles in a high-risk diabetes population. Methods: Here, we report the results of lipid profile values of 11,254 (yoga 5932 and control 5322) adults (20–70 years) of both genders with high risk (≥60 on Indian diabetes risk score) for diabetes from a nationwide rural and urban community-based two group (yoga and conventional management) cluster randomized controlled trial. The yoga group practiced a validated integrated yoga lifestyle protocol (DYP) in nine day camps followed by daily one-hour practice. Biochemical profiling included glycated hemoglobin and lipid profiles before and after three months. Results: There was a significant difference between groups (p < 0.001 ANCOVA) with improved serum total cholesterol, triglycerides, low-density lipoprotein, and high-density lipoprotein in the yoga group compared to the control group. Further, the regulatory effect of yoga was noted with a significant decrease or increase in those with high or low values of lipids, respectively, with marginal or no change in those within the normal range. Conclusion: Yoga lifestyle improves and regulates (lowered if high, increased if low) the blood lipid levels in both genders of prediabetic and diabetic individuals in both rural and urban Indian communities.

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