scholarly journals Vaginal probiotic adherence and acceptability in Rwandan women with high sexual risk participating in a pilot randomised controlled trial: a mixed-methods approach

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e031819
Author(s):  
Marijn C Verwijs ◽  
Stephen Agaba ◽  
Marie Michele Umulisa ◽  
Mireille Uwineza ◽  
Adrien Nivoliez ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Sexual Risk ◽  
Controlled Trial ◽  
Vaginal Infections ◽  
Pilot Randomised Controlled Trial ◽  
Steady Partner ◽  
Face To Face ◽  
Male Clients ◽  
Randomised Controlled

ObjectivesTo evaluate adherence and acceptability of intermittent vaginal probiotic or antibiotic use to prevent bacterial vaginosis (BV) recurrence.DesignRepeated adherence and acceptability assessments using mixed methods within a pilot randomised controlled trial.SettingResearch clinic in Kigali, Rwanda.ParticipantsRwandan women with high sexual risk.InterventionsWomen diagnosed with BV and/or trichomoniasis were randomised to four groups (n=17 each) after completing metronidazole treatment: behavioural counselling only, or behavioural counselling plus 2-month intermittent use of oral metronidazole, Ecologic Femi+ (EF+) vaginal capsule or Gynophilus LP (GynLP) vaginal tablet.Outcome measuresAdherence and acceptability were assessed by structured face-to-face interviews, semi-structured focus group discussions and in-depth interviews, daily diaries and counting of used/unused study products in randomised women (n=68). Vaginal infection knowledge was assessed by structured face-to-face interviews in randomised women and women attending recruitment sessions (n=131).ResultsMost women (93%) were sex workers, 99.2% were unfamiliar with BV and none had ever used probiotics. All probiotic users (n=32) reported that insertion became easier over time. Triangulated adherence data showed that 17/17 EF+ users and 13/16 GynLP users used ≥80% of required doses (Fisher’s exact p=0.103). Younger age (p=0.076), asking many questions at enrolment (p=0.116), having menses (p=0.104) and reporting urogenital symptoms (p=0.103) were non-significantly associated with lower perfect adherence. Women believed that the probiotics reduced BV recurrence, but reported that partners were sometimes unsupportive of study participation. Self-reported vaginal washing practices decreased during follow-up, but sexual risk behaviours did not. Most women (12/15) with an uncircumcised steady partner discussed penile hygiene with him, but many women found this difficult, especially with male clients.ConclusionsHigh-risk women require education about vaginal infections. Vaginal probiotic acceptability and adherence were high in this cohort. Our results can be used to inform future product development and to fine-tune counselling messages in prevention programmes.Trial registration numberNCT02459665.

scholarly journals Home-based exercise for people living with frailty and chronic kidney disease: A mixed-methods pilot randomised controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0251652
Author(s):  
Andrew C. Nixon ◽  
Theodoros M. Bampouras ◽  
Helen J. Gooch ◽  
Hannah M. L. Young ◽  
Kenneth W. Finlayson ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Kidney Disease ◽  
Usual Care ◽  
Controlled Trial ◽  
Pilot Randomised Controlled Trial ◽  
Home Based ◽  
Pilot Rct ◽  
Randomised Controlled

Background Frailty is associated with adverse health outcomes in people with chronic kidney disease (CKD). Evidence supporting targeted interventions is needed. This pilot randomised controlled trial (RCT) aimed to inform the design of a definitive RCT evaluating the effectiveness of a home-based exercise intervention for pre-frail and frail older adults with CKD. Methods Participants were recruited from nephrology outpatient clinics to this two-arm parallel group mixed-methods pilot RCT. Inclusion criteria were: ≥65 years old; CKD G3b-5; and Clinical Frailty Scale score ≥4. Participants categorised as pre-frail or frail using the Frailty Phenotype were randomised to a 12-week progressive multi-component home-based exercise programme or usual care. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion and participant attrition rate. Semi-structured interviews were conducted with participants to explore trial and intervention acceptability. Results Six hundred and sixty-five patients had an eligibility assessment with 217 (33%; 95% CI 29, 36) eligible. Thirty-five (16%; 95% CI 12, 22) participants were recruited. Six were categorised as robust and withdrawn prior to randomisation. Fifteen participants were randomised to exercise and 14 to usual care. Eleven (73%; 95% CI 45, 91) participants completed ≥2 exercise sessions/week. Retained participants completed all outcome measures (n = 21; 100%; 95% CI 81, 100). Eight (28%; 95% CI 13, 47) participants were withdrawn. Fifteen participated in interviews. Decision to participate/withdraw was influenced by perceived risk of exercise worsening symptoms. Participant perceived benefits included improved fitness, balance, strength, well-being, energy levels and confidence. Conclusions This pilot RCT demonstrates that progression to definitive RCT is possible provided recruitment and retention challenges are addressed. It has also provided preliminary evidence that home-based exercise may be beneficial for people living with frailty and CKD. Trial registration ISRCTN87708989; https://clinicaltrials.gov/.

scholarly journals Progressive functional exercise versus best practice advice for adults aged 50 years or over after ankle fracture: protocol for a pilot randomised controlled trial in the UK - the Ankle Fracture Treatment: Enhancing Rehabilitation (AFTER) study

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e030877
Author(s):  
David J Keene ◽  
Matthew L Costa ◽  
Elizabeth Tutton ◽  
Sally Hopewell ◽  
Vicki S Barber ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Ankle Fracture ◽  
Best Practice ◽  
Controlled Trial ◽  
Fracture Treatment ◽  
Pilot Randomised Controlled Trial ◽  
Face To Face ◽  
Functional Exercise ◽  
Randomised Controlled ◽  
The Uk

IntroductionAnkle fractures result in significant morbidity in adults, with prognosis worsening with increasing age. Previous trials have not found evidence supporting supervised physiotherapy sessions, but these studies have not focused on older adults or tailored the exercise interventions to the complex needs of this patient group. The Ankle Fracture Treatment: Enhancing Rehabilitation study is a pilot randomised controlled trial to assess feasibility of a later definitive trial comparing best-practice advice with progressive functional exercise for adults aged 50 years and over after ankle fracture.The main objectives are to assess: (i) patient engagement with the trial, measured by the participation rate of those eligible; (ii) establish whether the interventions are acceptable to participants and therapists, assessed by intervention adherence levels, participant interviews and a therapist focus group; (iii) participant retention in the trial, measured by the proportion of participants providing outcome data at 6 months; (iv) acceptability of measuring outcomes at 3 and 6 month follow-up.Methods and analysisA multicentre pilot randomised controlled trial with an embedded qualitative study. At least 48 patients aged 50 years and over with an ankle fracture requiring surgical management, or non-operative management by immobilisation for at least 4 weeks, will be recruited from a minimum of three National Health Service hospitals in the UK. Participants will be allocated 1:1 via a central web-based randomisation system to: (i) best-practice advice (one session of face-to-face self-management advice delivered by a physiotherapist and up to two optional additional sessions) or (ii) progressive functional exercise (up to six sessions of individual face-to-face physiotherapy). An embedded qualitative study will include one-to-one interviews with up to 20 participants and a therapist focus group.Ethics and disseminationHampshire B Research Ethics Committee (18/SC/0281) gave approval on 2nd July 2018.Trial registration numberISRCTN16612336

scholarly journals Implementing self-management: a mixed-methods study of women’s experiences of a postpartum hypertension intervention (SNAP-HT)

2020 ◽  
Author(s):  
Alexandra Elspeth Cairns ◽  
Katherine L. Tucker ◽  
Carole Crawford ◽  
Richard J. McManus ◽  
John Powell
Keyword(s):  
Blood Pressure ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Blood Pressure Monitoring ◽  
Controlled Trial ◽  
Mixed Methods Study ◽  
Self Management ◽  
Normalisation Process Theory ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management, in women with medicated hypertensive disorders of pregnancy. Methods A mixed methods study using semi-structured interviews with a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial (SNAP-HT) in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups optionally consented to participate in audio-recorded interviews, at four weeks and six months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of Normalisation Process Theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach. Results Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both four weeks and six months: adjusted differences 0.6 (95% confidence interval (CI) 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. Conclusions Interviews and quantitative data showed that self-management enhanced women’s sense of control, and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible, reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum, and reinforce the effectiveness of the intervention used in this study. Trial registration Prospectively registered with ClinicalTrials.gov on 07/01/2015 (NCT02333240) https://clinicaltrials.gov/ct2/show/NCT02333240.

scholarly journals Implementing self-management: a mixed-methods study of women’s experiences of a postpartum hypertension intervention

2019 ◽  
Author(s):  
Alexandra Elspeth Cairns ◽  
Katherine L. Tucker ◽  
Carole Crawford ◽  
Richard J. McManus ◽  
John Powell
Keyword(s):  
Blood Pressure ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Blood Pressure Monitoring ◽  
Controlled Trial ◽  
Mixed Methods Study ◽  
Self Management ◽  
Normalisation Process Theory ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated that adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management, in women with medicated hypertensive disorders of pregnancy. Methods A mixed methods study using semi-structured interviews with both a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups consented to participate in audio-recorded interviews, at four weeks and six months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of Normalisation Process Theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach. Results Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both four weeks and six months: adjusted differences 0.6 (95% confidence interval (CI) 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. Conclusions Interviews and quantitative data showed that self-management enhanced women’s sense of control, and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible, reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum, and reinforce the effectiveness of the intervention used in this study. Trial registration Prospectively registered with ClinicalTrials.gov on 07/01/2015 (NCT02333240) https://clinicaltrials.gov/ct2/show/NCT02333240.

Habits-GDM mobile application in managing gestational diabetes in Singapore: A mixed-methods study (Preprint)

2020 ◽  
Author(s):  
Shilpa Surendran ◽  
Chang Siang Lim ◽  
Gerald Choon Huat Koh ◽  
Tong Wei Yew ◽  
E Shyong Tai ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Gestational Diabetes ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Perceived Usefulness ◽  
Mixed Methods Study ◽  
Automatic Data ◽  
Glucose Testing ◽  
Randomised Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing in Singapore and the cost of providing traditional care for GDM is high. Mobile health (mHealth) applications may act as useful tools in the management of GDM. OBJECTIVE The objective of this mixed-methods study was to measure the usage behaviour and explore users’ perceived usefulness of the Habits-GDM application when managing GDM in a randomised controlled trial. METHODS We conducted a quantitative analysis of the application usage behaviour in 170 Habits-GDM application users and 14 semi-structured interviews with users from a randomised controlled trial. RESULTS The convenience of automatic data transfer of weight values to the Habits-GDM application helped users (116/170, 68%) log their weight at least once a week. However, when the application had usability challenges, users avoided using that feature, i.e. users logged only an average of less than one meal/week out of the recommended six meals/week. Of the usability challenges, many users (12/14, 85.7%) mentioned food items not worded in the commonly known way and limited ethnic food database as the primary barriers. Only half of the users (84/170, 49.4%) accessed the educational lessons, but many (9/14, 64%) identified the provision of always available, valuable health-related information as an advantage of the educational lessons. ‘Healthy eating’ and ‘Why exercise’ were the most (56/84, 66.67%) and least (38/84, 45.24%) frequently accessed educational lessons, respectively. Users (10/14, 71.4%) reported sending messages to the coach via the chat interface only when they faced logistic issues and 86.45% of all the coach messages were replies typed by the research coordinator in response to the logistics issues (i.e. a request for blood glucose testing strips and appointment confirmation) raised by the users. Healthcare professionals lack of access to the coach’s dashboard discouraged users from asking queries related to GDM via the e-coaching feature. CONCLUSIONS The findings suggest that mHealth application acts as a useful tool in managing GDM. Culturally sensitive mHealth applications with a provision for women to interact with healthcare professionals should be developed in cooperation with the users. CLINICALTRIAL Not applicable.

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