Improving Bereavement Outcomes in Zimbabwe: Results of a Feasibility Cluster Trial of the 9-Cell Bereavement Tool

Abstract ContextDespite high mortality rates from both communicable and non-communicable diseases, bereavement studies are under-researched in African countries. The 9-cell bereavement tool was designed to assist individuals to reflect on their feelings in bereavement, and identify resources in families and communities to manage bereavement. This study aimed to determine the feasibility of implementing the 9-cell bereavement tool and recruitment to experimental evaluation. Methods: A feasibility cluster randomized trial with embedded qualitative interviews was conducted in two comparable neighborhoods in Chitungwiza, Zimbabwe. Community leaders identified potential community lay bereavement supporters (interventionists). Each recruited 2-3 recently bereaved community members (trial participants). Following baseline data collection, the communities were randomly allocated to intervention or wait-list control. Self-administered questionnaires were completed at T0 (month 0), T1(3 months) and T2 (6 months). Grief, mental health and social support were assessed. Focus group discussions with selected interventionists described training impact and intervention processes. Quantitative and qualitative analysis were performed. ResultsObjectives were achieved as follows(i) feasibility of recruitment and retention (ii) feasibility of implementing the intervention (iii) determining contamination(iv) completeness of data(v) participants’ views on intervention and mechanisms(vi) estimating potential effect size (vii) determining whether full trial warranted. In line with the aim of the study, the processes of the randomized cluster trial were possible. We successfully conducted the randomized control trial of the 9-cell bereavement tool and successfully recruited study participants. In addition, the 9-cell intervention allowed interventionists to share and learn from their grieving process. All of the above was conducted within the intended timeframe of 3 weeks, with an over recruitment of 112% of interventionists and 43% more trial participants. This means we were able to recruit at least 75% of the suggested sample size; and to retain at least 75% of the trial participants for the total duration of the study. Conclusion The processes of the randomized controlled trial were possible. The 9-cell bereavement intervention was delivered and process data assessed. The study was funded through the BuildCARE fund from the Cicely Saunders Institute of Palliative Care, Policy and Rehabilitation Protocol Registration: http://www.isrctn.com/ISRCTN16484746.Protocol Publication: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0450-5

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The effect of practicing yoga during pregnancy on labor stages length, anxiety and pain: a randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2019-0291 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Ellahe Mohyadin ◽

Zohreh Ghorashi ◽

Zahra Molamomanaei

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Total Duration ◽

Measurement Data ◽

Labor Pain ◽

Control Group ◽

Chi Square ◽

Nulliparous Women ◽

Two Stages ◽

And Control

AbstractBackgroundAnxiety and fear of labor pain has led to elevated cesarean section rate in some countries. This study was conducted to investigate the effect of yoga in pregnancy on anxiety, labor pain and length of labor stages.MethodsThis clinical trial study was performed on 84 nulliparous women who were at least 18 years old and were randomly divided into two groups of yoga and control groups. Pregnancy Yoga Program consisting of 6 60-min training sessions was started every 2 weeks from week 26 of pregnancy and continued until 37 weeks of gestation. Anxiety severity at maternal admission to labor was measured by the Spielbergers State-Trait Anxiety Inventory, and labor pain was measured by Visual Analogue Scale (VAS) at dilatation (4–5 cm) and 2 h after the first measurement. Data were analyzed using Chi-Square and t-test.ResultsIntervention group reported less pain at dilatation (4–5 cm) (p=0.001) and 2 h after the first measurement (p=0.001) than the control group. Stat anxiety was also lower in intervention group than the control group (p=0.003) at the entrance to labor room. Subjects in the control group required more induction compared to intervention group (p=0.003). Women in intervention group experienced shorter duration of the first phase of the labor than the control group (p=0.002). Also, the total duration of two stages of labor was shorter in intervention group than the control group (p=0.003).ConclusionsPracticing yoga during pregnancy may reduce women’s anxiety during labor; shorten labor stages, and lower labor pain.

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Competing interests, clashing ideas and institutionalizing influence: insights into the political economy of malaria control from seven African countries

Health Policy and Planning ◽

10.1093/heapol/czaa166 ◽

2020 ◽

Author(s):

Justin Parkhurst ◽

Ludovica Ghilardi ◽

Jayne Webster ◽

Robert W Snow ◽

Caroline A Lynch

Keyword(s):

Decision Making ◽

Malaria Control ◽

Qualitative Interviews ◽

Sub Saharan Africa ◽

African Countries ◽

Health Community ◽

Control Programmes ◽

Control Decision ◽

Sub Saharan ◽

Economic Considerations

Abstract This article explores how malaria control in sub-Saharan Africa is shaped in important ways by political and economic considerations within the contexts of aid-recipient nations and the global health community. Malaria control is often assumed to be a technically driven exercise: the remit of public health experts and epidemiologists who utilize available data to select the most effective package of activities given available resources. Yet research conducted with national and international stakeholders shows how the realities of malaria control decision-making are often more nuanced. Hegemonic ideas and interests of global actors, as well as the national and global institutional arrangements through which malaria control is funded and implemented, can all influence how national actors respond to malaria. Results from qualitative interviews in seven malaria-endemic countries indicate that malaria decision-making is constrained or directed by multiple competing objectives, including a need to balance overarching global goals with local realities, as well as a need for National Malaria Control Programmes to manage and coordinate a range of non-state stakeholders who may divide up regions and tasks within countries. Finally, beyond the influence that political and economic concerns have over programmatic decisions and action, our analysis further finds that malaria control efforts have institutionalized systems, structures and processes that may have implications for local capacity development.

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Cooking for Vitality: Pilot Study of an Innovative Culinary Nutrition Intervention for Cancer-Related Fatigue in Cancer Survivors

Nutrients ◽

10.3390/nu12092760 ◽

2020 ◽

Vol 12 (9) ◽

pp. 2760

Author(s):

Cheryl Pritlove ◽

Geremy Capone ◽

Helena Kita ◽

Stephanie Gladman ◽

Manjula Maganti ◽

...

Keyword(s):

Cancer Survivors ◽

Controlled Trial ◽

Qualitative Interviews ◽

Energy Levels ◽

Nutrition Intervention ◽

Management Skills ◽

Cooking Skills ◽

Patients With Cancer ◽

Cancer Related Fatigue ◽

Poor Nutritional Status

(1) Background: Cancer-related fatigue (CRF) is one of the most prevalent and distressing side effects experienced by patients with cancer during and after treatment, and this negatively impacts all aspects of quality of life. An increasing body of evidence supports the role of poor nutritional status in the etiology of CRF and of specific diets in mitigating CRF. We designed a group-based two session culinary nutrition intervention for CRF, Cooking for Vitality (C4V), aimed at increasing understanding of how food choices can impact energy levels and establishing basic food preparation and cooking skills as well as the application of culinary techniques that minimize the effort/energy required to prepare meals. The purpose of this pilot mixed-method study was to evaluate: Feasibility of the experimental methods and intervention; acceptability and perceived helpfulness of intervention; and to obtain a preliminary estimate of the effectiveness of the intervention on fatigue (primary outcome), energy, overall disability, and confidence to manage fatigue (secondary outcomes). (2) Methods: Prospective, single arm, embedded mixed-methods feasibility study of cancer survivors with cancer-related fatigue was conducted. Participants completed measures at baseline (T0), immediately following the intervention (T1), and three months after the last session (T2). Qualitative interviews were conducted at T2. (3) Results: Recruitment (70%) and retention (72%) rates along with qualitative findings support the feasibility of the C4V intervention for cancer survivors living with CRF (program length and frequency, ease of implementation, and program flexibility). Acceptability was also high and participants provided useful feedback for program improvements. Fatigue (FACT-F) scores significantly improved from T0–T1 and T0–T2 (p < 0.001). There was also a significant decrease in disability scores (WHO-DAS 2.0) from T0–T2 (p = 0.006) and an increase in POMS-Vigor (Profile of Mood States) from T0–T1 (p = 0.018) and T0–T2 (p = 0.013). Confidence in managing fatigue improved significantly from T0–T1 and T0–T2 (p < 0.001). (4) Conclusions: The results suggest that the C4V program was acceptable and helpful to patients and may be effective in improving fatigue levels and self-management skills. A randomized controlled trial is required to confirm these findings.

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A novel ACT-based video game to support mental health through embedded learning: a mixed-methods feasibility study protocol

BMJ Open ◽

10.1136/bmjopen-2020-041667 ◽

2020 ◽

Vol 10 (11) ◽

pp. e041667

Author(s):

Darren J Edwards ◽

Andrew H Kemp

Keyword(s):

Mental Health ◽

Mixed Methods ◽

Video Game ◽

Emotional Regulation ◽

Cognitive Skills ◽

Controlled Trial ◽

Qualitative Interviews ◽

Mental Health Disorder ◽

Acceptance And Commitment ◽

Randomised Controlled

IntroductionIn recent years, serious video games have been used to promote emotional regulation in individuals with mental health issues. Although these therapeutic strategies are innovative, they are limited with respect to scope of treatment, often focusing on specific cognitive skills, to help remediate a specific mental health disorder.ObjectiveHere, we propose a protocol for assessing the feasibility of a novel acceptance and commitment therapy (ACT)-based video game for young adults.Methods and analysisThe Medical Research Council (MRC) framework will be used for developing a complex intervention to design and test the feasibility of an ACT-based video game intervention using a mixed-methods approach involving qualitative and quantitative data. The primary outcomes will include feasibility testing of recruitment processes and the acceptability of the intervention through qualitative interviews, attendance and rates of attrition. Secondary outcomes will involve a series of quantitative questionnaires to obtain effect sizes for power analysis, allowing for the ideal sample size for an appropriately powered, randomised controlled trial to be determined.Ethics and disseminationThis study has been approved by the Psychology Department Research Ethics Committee (2020-4929-3923) at Swansea University in the UK. Dissemination activities will involve publications in peer-reviewed journals, presentations at local and national conferences and promotion through social media.Trial registration numberNCT04566042.

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Does #Tamojunto alter the dynamic between drug use and school violence among youth? Secondary analysis from a large cluster-randomized trial

European Child & Adolescent Psychiatry ◽

10.1007/s00787-021-01863-x ◽

2021 ◽

Author(s):

Hugo Cogo-Moreira ◽

Julia D. Gusmões ◽

Juliana Y. Valente ◽

Michael Eid ◽

Zila M. Sanchez

Keyword(s):

Drug Use ◽

School Violence ◽

Causal Effect ◽

Controlled Trial ◽

Secondary Analysis ◽

Cluster Randomized Trial ◽

Random Intercept ◽

Carry Over ◽

Cluster Randomized ◽

Use Behavior

AbstractThe present study investigated how intervention might alter the relationship between perpetrating violence and later drug use. A cluster-randomized controlled trial design involving 72 schools (38 intervention, 34 control) and 6390 students attending grades 7 and 8 was employed in Brazil. Drug use and violence were assessed at three points. A random-intercept cross-lagged panel model examined the reciprocal association between drug use and school violence domains across the three data collection waves. For both groups, we found that the cross-lagged effect of perpetration on further drug use in adolescents was stronger than the reverse, but the interrelationship was not statistically significant between #Tamojunto and control schools. The carry-over effects of drug use and violence were also not significantly different between groups. There is a lack of evidence showing that #Tamojunto can modify the dynamics between drug use and school violence across the 21-month period. The direction of the causal effect (i.e., the more perpetration behavior, the more subsequent drug use behavior) is present, but weak in both groups. The trial registration protocol at the national Brazilian Register of Clinical Trials (REBEC) is #RBR-4mnv5g.

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Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma

BMC Ophthalmology ◽

10.1186/s12886-020-01776-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Abdou Amza ◽

Boubacar Kadri ◽

Beido Nassirou ◽

Ahmed M. Arzika ◽

Ariana Austin ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Clinical Signs ◽

Cluster Randomized Trial ◽

World Health ◽

Baseline Assessment ◽

Randomized Controlled ◽

Registration Number ◽

Cluster Randomized ◽

Health Organization

Abstract Background The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation—follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines. Methods The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3 years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission. Discussion The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. Trial registration number This study is registered at clinicaltrials.gov (NCT04185402). Registered December 4, 2019; prospectively registered pre-results.

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O-196 The impact of providing couples with their IVF-prognosis on the expectations and anxiety of women and men

Human Reproduction ◽

10.1093/humrep/deab128.007 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

J Devroe ◽

K Peeraer ◽

T D’Hooghe ◽

J Boivin ◽

J Vriens ◽

...

Keyword(s):

Embryo Transfer ◽

Mixed Models ◽

Controlled Trial ◽

Qualitative Interviews ◽

Linear Mixed Models ◽

Gender Effect ◽

Prognostic Models ◽

Fresh Embryo Transfer ◽

Random Factor ◽

The Impact

Abstract Study question What is the impact of providing couples with their IVF-prognosis on expectations and anxiety in women and men on the day of embryo transfer? Summary answer Only couples with a less than average IVF-prognosis updated their high expectations and IVF-prognosis was negatively associated with anxiety, especially in women. What is known already Female IVF-patients are known to expect a pregnancy rate per IVF-cycle of no less than 49-55%. Qualitative interviews and a survey showed that well informed women expect unrealistically high pregnancy rates as they think that their (family’s) fertility and their clinic is better than average. Several prognostic models have recently been published. The adapted van Loendersloot model including clinical and laboratory characteristics proved performant for our clinic (AUC=0.74) and was validated internally (Devroe et al, BMJ Open, 2020). The impact of providing couples with their IVF-prognosis on expectations and wellbeing of female and male patients has yet to be studied. Study design, size, duration A prospective survey, questioning a final sample of 148 partnered individuals, completing their 2nd-6th IVF-cycle (2019-2020) in a University clinic, on the days of oocyte aspiration (OA) and fresh embryo transfer (ET). Thirty other partnered individuals declined participation (participation rate=85%) and 26 were excluded due to ET-cancellation. The IVF-prognosis (live birth rate, LBR, per completed IVF-cycle including fresh and frozen ETs from the same ovarian stimulation) was calculated with the adapted van Loendersloot model. Participants/materials, setting, methods Each partner reported their perception of their expected IVF-LBR on a visual analogue scale on the day OA. After being informed on their IVF-prognosis by gynaecologists, they re-rated their expected IVF-LBR and filled out the reliable ‘STAI-State-Anxiety Inventory’ on the day of fresh ET. Linear mixed models, taking account of partnering and assessing the association with gender, explored whether individuals updated their expected IVF-LBR after receiving their IVF-prognosis and whether IVF-prognosis and anxiety were associated. Main results and the role of chance The mean IVF-prognosis was 30.9% (±16.8). The 148 partnered individuals had a mean expected IVF-LBR of 59.1% (±20.0) on the day of OA (no gender effect; p = 0.079). After being informed on their IVF-prognosis (day of ET), women’s and men’s mean expected IVF-LBR was 50.9% (±24.5) and 58.1% (±22.1), respectively (gender effect; p = 0.002). Linear mixed models, including couple and time as random factors, did not show an effect of time on expected IVF-LBRs (p = 0.15). Although women were more likely than men to update their expected IVF-LBR (p = 0.002), the updates were not significantly different from the IVF-LBR expected on the day of OA (p = 0.10). Women were more anxious than men (41.5±10.6 and 21.9±7.2, respectively, p < 0.001) after being given their IVF-prognosis. Linear mixed models, including couple as a random factor, showed an association between IVF-prognosis and anxiety (p = 0.016), especially in women (gender effect; p = 0.004). Subgroup analysis showed that partnered individuals with lower than average prognoses (n = 78) did update their expected IVF-LBR (p = 0.036) while others (n = 70) did not update their expected IVF-LBR (p = 0.761). Among the subgroup with lower prognoses women were more likely to update their expected IVF-LBR than men (p = 0.013), while no gender effect was observed among the subgroup with higher IVF-prognoses (p = 0.078). Limitations, reasons for caution This is an explorative study in preparation of an adequately powered randomized controlled trial, testing whether couples who are informed on their IVF-prognosis update their expected IVF-LBR and whether this causes anxiety, as compared to care as usual in which couples are not informed on their IVF-prognosis. Wider implications of the findings Men and especially women with a less than average prognosis update their IVF-expectations after having received this prognosis which may trigger anxious reactions. These findings should be re-examined in an RCT. Following up the effect of sharing IVF-prognoses on longer-term distress and IVF-discontinuation would be interesting. Trial registration number not applicable

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Improving the Care of People with Long-Term Conditions in Primary Care: Protocol for the Enhance Pilot Trial

Journal of Comorbidity ◽

10.15256/joc.2015.5.60 ◽

2015 ◽

Vol 5 (1) ◽

pp. 135-149 ◽

Cited By ~ 3

Author(s):

Emma L. Healey ◽

Clare Jinks ◽

Valerie A. Tan ◽

Carolyn A. Chew-Graham ◽

Sarah A. Lawton ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Qualitative Interviews ◽

Pilot Trial ◽

Integrated Approach ◽

Long Term Conditions ◽

Delivery Of Care ◽

Care Protocol ◽

Engagement Assessment

Background Long-term conditions (LTCs) are important determinants of quality of life and healthcare expenditure worldwide. Whilst multimorbidity is increasingly the norm in primary care, clinical guidelines and the delivery of care remain focused on single diseases, resulting in poorer clinical outcomes. Osteoarthritis, and anxiety and/or depression frequently co-occur with other LTCs, yet are seldom prioritized by the patient or clinician, resulting in higher levels of disability, poorer prognosis, and increased healthcare costs. Objective To examine the feasibility and acceptability of an integrated approach to LTC management, tackling the under-diagnosis and under-management of osteoarthritis-related pain and anxiety and/or depression in older adults with other LTCs in primary care. Design The ENHANCE study is a pilot stepped-wedge cluster randomized controlled trial to test the feasibility and acceptability of a nurse-led ENAHNCE LTC review consultation for identifying, assessing, and managing joint pain, and anxiety and/or depression in patients attending LTC reviews. Specific objectives (process evaluation and research outcomes) will be achieved through a theoretically informed mixed-methods approach using participant self-reported questionnaires, a medical record review, an ENHANCE EMIS template, qualitative interviews, and audio recordings of the ENHANCE LTC review. Discussion Success of the pilot trial will be measured against the level of the primary care team engagement, assessment of training delivery, and degree of patient recruitment and retention. Patient satisfaction and treatment fidelity will also be explored. ISRCTN registry number: 12154418.

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Acceptability of a vocational advice service for patients consulting in primary care with musculoskeletal pain: A qualitative exploration of the experiences of general practitioners, vocational advisers and patients

Scandinavian Journal of Public Health ◽

10.1177/1403494817723194 ◽

2017 ◽

Vol 47 (1) ◽

pp. 78-85 ◽

Cited By ~ 2

Author(s):

Tom Sanders ◽

Gwenllian Wynne-Jones ◽

Bie Nio Ong ◽

Majid Artus ◽

Nadine Foster

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Comparative Method ◽

Qualitative Interviews ◽

Cluster Randomised Controlled Trial ◽

Key Factors ◽

Constant Comparative Method ◽

General Practices ◽

Randomised Controlled ◽

Qualitative Exploration

Aims: Using qualitative interviews, this study explored the experiences of GPs, vocational advisers and patients towards a new vocational advice (VA) service in primary care. Methods: This study was nested within the Study of Work and Pain (SWAP) cluster randomised controlled trial. The SWAP trial located a VA service within three general practices in Staffordshire. Interviews took place with 10 GPs 12 months after the introduction of the VA service, four vocational advisers whilst the VA service was running and 20 patients on discharge from the VA service. The data were analysed using the constant comparative method, which is a variation of grounded theory. Results: The key factors determining the acceptability and perceived effectiveness of the VA service from the perspective of the three groups of stakeholders were (1) the timing of referrals to the VA, (2) the perceived lack of patient demand for the service and (3) role uncertainty experienced by VAs. Conclusions: Early vocational intervention may not be appropriate for all musculoskeletal patients with work difficulties. Indeed, many patients felt they did not require the support of a VA, either because they had self-limiting work difficulties and/or already had support mechanisms in place to return to work. Future VA interventions may be better implemented in a targeted way so that appropriate patients are identified with characteristics which can best be addressed by the VA service.

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Reflections on Hip Fracture Recovery From Older Adults Enrolled in a Clinical Trial

Gerontology and Geriatric Medicine ◽

10.1177/2333721417697663 ◽

2017 ◽

Vol 3 ◽

pp. 233372141769766 ◽

Cited By ~ 4

Author(s):

Sarah Stott-Eveneshen ◽

Joanie Sims-Gould ◽

Megan M. McAllister ◽

Lena Fleig ◽

Heather M. Hanson ◽

...

Keyword(s):

Social Support ◽

Older Adults ◽

Hip Fracture ◽

Controlled Trial ◽

Qualitative Interviews ◽

Management Program ◽

Knowledge Resources ◽

Study Staff ◽

Fracture Management ◽

Positive Perspective

This study describes patients’ perspectives on recovery during participation in a randomized controlled trial that tested a postoperative hip fracture management program (B4 Clinic), compared with usual care, on mobility. Semistructured qualitative interviews were conducted with 50 older adults with hip fracture (from both groups) twice over 12 months. A total of 32 women (64%) and 18 men (36%) participated in the study with a mean age at baseline of 82 (range = 65-98) years. A total of 40 participants reported recovery goals at some point during their recovery from hip fracture but only 18 participants realized their goals within 12 months. Recovering mobility, returning to prefracture activities, and obtaining stable health were the most commonly reported goals. Participants described good social support, access to physiotherapy, and positive perspective as most important to recovery. These factors were influenced by participants’ knowledge, resources, and monthly contact with study staff (perceived as a form of social support). The most frequently reported barriers to participants’ recovery were the onset of complications, pain, and limited access to physiotherapy. Potential implications of these findings include design and modification of new or preexisting fracture programs, prioritizing patient engagement and enhanced knowledge for future clinical research in hip fracture recovery.

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