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Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

ABSTRACT: BACKGROUND: Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. METHODS: TRIAL DESIGN: Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. OBJECTIVE: To evaluate the effectiveness of the group diabetes education programmeOutcomes: PRIMARY OUTCOMES: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. SECONDARY OUTCOMES: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. DISCUSSION: The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. TRIAL REGISTER: Pan African Clinical Trial Registry PACTR201205000380384.

SUBMITTER: Mash B

PROVIDER: S-EPMC3560091 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

Mash Bob B Levitt Naomi N Steyn Krisela K Zwarenstein Merrick M Rollnick Stephen S

BMC family practice 20121224

<h4>Background</h4>Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life.<h4>Methods</h4><h4>Trial design</h4>Pragmatic c ...[more]

PMID: 23265076

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Project description:Objective:To assess the impact of 'Parenting for Lifelong Health: Sinovuyo Teen', a parenting programme for adolescents in low-income and middle-income countries, on abuse and parenting practices. Design:Pragmatic cluster randomised controlled trial. Setting:40 villages/urban sites (clusters) in the Eastern Cape province, South Africa. Participants:552 families reporting conflict with their adolescents (aged 10-18). Intervention:Intervention clusters (n=20) received a 14-session parent and adolescent programme delivered by trained community members. Control clusters (n=20) received a hygiene and hand-washing promotion programme. Main outcome measures:Primary outcomes: abuse and parenting practices at 1 and 5-9 months postintervention. Secondary outcomes: caregiver and adolescent mental health and substance use, adolescent behavioural problems, social support, exposure to community violence and family financial well-being at 5-9 months postintervention. Blinding was not possible. Results:At 5-9 months postintervention, the intervention was associated with lower abuse (caregiver report incidence rate ratio (IRR) 0.55 (95% CI 0.40 to 0.75, P<0.001); corporal punishment (caregiver report IRR=0.55 (95% CI 0.37 to 0.83, P=0.004)); improved positive parenting (caregiver report d=0.25 (95% CI 0.03 to 0.47, P=0.024)), involved parenting (caregiver report d=0.86 (95% CI 0.64 to 1.08, P<0.001); adolescent report d=0.28 (95% CI 0.08 to 0.48, P=0.006)) and less poor supervision (caregiver report d=-0.50 (95% CI -0.70 to -0.29, P<0.001); adolescent report d=-0.34 (95% CI -0.55 to -0.12, P=0.002)), but not decreased neglect (caregiver report IRR 0.31 (95% CI 0.09 to 1.08, P=0.066); adolescent report IRR 1.46 (95% CI 0.75 to 2.85, P=0.264)), inconsistent discipline (caregiver report d=-0.14 (95% CI -0.36 to 0.09, P=0.229); adolescent report d=0.03 (95% CI -0.20 to 0.26, P=0.804)), or adolescent report of abuse IRR=0.90 (95% CI 0.66 to 1.24, P=0.508) and corporal punishment IRR=1.05 (95% CI 0.70 to 1.57, P=0.819). Secondary outcomes showed reductions in caregiver corporal punishment endorsement, mental health problems, parenting stress, substance use and increased social support (all caregiver report). Intervention adolescents reported no differences in mental health, behaviour or community violence, but had lower substance use (all adolescent report). Intervention families had improved economic welfare, financial management and more violence avoidance planning (in caregiver and adolescent report). No adverse effects were detected. Conclusions:This parenting programme shows promise for reducing violence, improving parenting and family functioning in low-resource settings. Trial registration number:Pan-African Clinical Trials Registry PACTR201507001119966.

Project description:Bullying refers to verbal, physical or psychological aggression repeated over time that is intended to cause harm or distress to the victims who are unable to defend themselves. It is a key public health priority owing to its widespread prevalence in schools and harmful short- and long-term effects on victims' well-being. There is a need to strengthen the evidence base by testing innovative approaches to preventing bullying. KiVa is a school-based bullying prevention programme with universal and indicated elements and an emphasis on changing bystander behaviour. It achieved promising results in a large trial in Finland, and now requires testing in other countries. This paper describes the protocol for a cluster randomised controlled trial (RCT) of KiVa in Wales.The study uses a two-arm waitlist control pragmatic definitive parallel group cluster RCT design with an embedded process evaluation and calculation of unit cost. Participating schools will be randomised a using a 1:1 ratio to KiVa plus usual provision (intervention group) or usual provision only (control group). The trial has one primary outcome, child self-reported victimisation from bullying, dichotomised as 'victimised' (bullied at least twice a month in the last couple of months) versus 'not victimised'. Secondary outcomes are: bullying perpetration; aspects of child social and emotional well-being (including emotional problems, conduct, peer relations, prosocial behaviour); and school attendance. Follow-up is at 12 months post-baseline. Implementation fidelity is measured through teacher-completed lesson records and independent school-wide observation. A micro-costing analysis will determine the costs of implementing KiVa, including recurrent and non-recurrent unit costs. Factors related to the scalability of the programme will be examined in interviews with head teachers and focus groups with key stakeholders in the implementation of school-based bullying interventions.The results from this trial will provide evidence on whether the KiVa programme is transportable from Finland to Wales in terms of effectiveness and implementation. It will provide information about the costs of delivery and generate insights into factors related to the scalability of the programme.Current Controlled Trials ISRCTN23999021 Date 10-6-13.

Project description:BackgroundPoverty undermines adherence to tuberculosis treatment. Economic support may both encourage and enable patients to complete treatment. In South Africa, which carries a high burden of tuberculosis, such support may improve the currently poor outcomes of patients on tuberculosis treatment. The aim of this study was to test the feasibility and effectiveness of delivering economic support to patients with pulmonary tuberculosis in a high-burden province of South Africa.MethodsThis was a pragmatic, unblinded, two-arm cluster-randomized controlled trial, where 20 public sector clinics acted as clusters. Patients with pulmonary tuberculosis in intervention clinics (n?=?2,107) were offered a monthly voucher of ZAR120.00 (approximately US$15) until the completion of their treatment. Vouchers were redeemed at local shops for foodstuffs. Patients in control clinics (n?=?1,984) received usual tuberculosis care.ResultsIntention to treat analysis showed a small but non-significant improvement in treatment success rates in intervention clinics (intervention 76.2%; control 70.7%; risk difference 5.6% (95% confidence interval: -1.2%, 12.3%), P?=?0.107). Low fidelity to the intervention meant that 36.2% of eligible patients did not receive a voucher at all, 32.3% received a voucher for between one and three months and 31.5% received a voucher for four to eight months of treatment. There was a strong dose-response relationship between frequency of receipt of the voucher and treatment success (P <0.001).ConclusionsOur pragmatic trial has shown that, in the real world setting of public sector clinics in South Africa, economic support to patients with tuberculosis does not significantly improve outcomes on treatment. However, the low fidelity to the delivery of our voucher meant that a third of eligible patients did not receive it. Among patients in intervention clinics who received the voucher at least once, treatment success rates were significantly improved. Further operational research is needed to explore how best to ensure the consistent and appropriate delivery of such support to those eligible to receive it.

Project description:BackgroundPeople with asthma from ethnic minority groups experience significant morbidity. Culturally-specific interventions to reduce asthma morbidity are rare. We tested the hypothesis that a culturally-specific education programme, adapted from promising theory-based interventions developed in the USA, would reduce unscheduled care for South Asians with asthma in the UK.MethodsA cluster randomised controlled trial, set in two east London boroughs. 105 of 107 eligible general practices were randomised to usual care or the education programme. Participants were south Asians with asthma aged 3 years and older with recent unscheduled care. The programme had two components: the Physician Asthma Care Education (PACE) programme and the Chronic Disease Self Management Programme (CDSMP), targeted at clinicians and patients with asthma respectively. Both were culturally adapted for south Asians with asthma. Specialist nurses, and primary care teams from intervention practices were trained using the PACE programme. South Asian participants attended an outpatient appointment; those registered with intervention practices received self-management training from PACE-trained specialist nurses, a follow-up appointment with PACE-trained primary care practices, and an invitation to attend the CDSMP. Patients from control practices received usual care. Primary outcome was unscheduled care.Findings375 south Asians with asthma from 84 general practices took part, 183 registered with intervention practices and 192 with control practices. Primary outcome data were available for 358/375 (95.5%) of participants. The intervention had no effect on time to first unscheduled attendance for asthma (Adjusted Hazard Ratio AHR = 1.19 95% CI 0.92 to 1.53). Time to first review in primary care was reduced (AHR = 2.22, (1.67 to 2.95). Asthma-related quality of life and self-efficacy were improved at 3 months (adjusted mean difference -2.56, (-3.89 to -1.24); 0.44, (0.05 to 0.82) respectively.ConclusionsA multi-component education programme adapted for south Asians with asthma did not reduce unscheduled care but did improve follow-up in primary care, self-efficacy and quality of life. More effective interventions are needed for south Asians with asthma.

Project description:BACKGROUND:The United Nation's Sustainable Development Goals encompass lifelong learning from birth to youth to adulthood (Goal 4) and economic opportunities for young people (Goal 8). The targets include improving access to quality early childhood care and education (ECCE) as well as learning and training opportunities for adolescents and youth. Cross-generational models for young children and youth may offer opportunities to address the interconnections between goals and targets for the next generation. We investigated whether an ECCE programme for young children (3.5-6.5 years) delivered by female youth (18-24 years) in rural Pakistan would be effective on children's school readiness. METHODS:In partnership with the National Commission for Human Development in Pakistan, we implemented the 'Youth Leaders for Early Childhood Assuring Children are Prepared for School' (LEAPS) programme to train female youth to deliver ECCE. The effectiveness of the LEAPS programme on children's school readiness was evaluated in a cluster-randomised controlled trial. We randomly allocated five clusters (villages) to receive the intervention (n = 170 children) and five clusters to control (n = 170 children). Children's school readiness was assessed after nine months of intervention exposure using the International Development and Early Learning Assessment tool. Analyses was by intention-to-treat. The trial is registered with ClinicalTrials.gov, number NCT02645162. FINDINGS:At endline, the intervention group had significantly higher school readiness scores (n = 166, mean percentage score 59.4, 95% CI 52.7 to 66.2) compared with the control group (n = 168, mean percentage score 45.5, 95% CI 38.8 to 52.3). The effect size (Cohen's d) was 0.3. CONCLUSION:Trained female youth delivered an ECCE programme that was effective in benefitting young children's school readiness. The cross-generational model is a promising approach to support early child development; however, further evaluation of the model is needed to assess the specific benefits to youth including their skills and economic development.

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Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

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Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

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