Is It Ethical to Assign Medically Underserved African Americans to a Usual-Care Control Group in Community-Based Intervention Research?

9617 Background: The quality of life (QOL) of cancer patients is often diminished due to the side effects of treatment and symptoms of the disease itself. This study examines the impact of Medical Qigong (MQ), including gentle exercise and relaxation through meditation and breathing exercise based on the Chinese Medicine theory of energy channels, on quality of life (QOL), fatigue, side effects, mood status and inflammation. Methods: One hundred sixty two patients diagnosed with a range of cancers recruited from three university teaching hospitals were randomly assigned to two groups: a control group (n=83) that received usual health care and an intervention group (n=79) who participated in a MQ program for 10 weeks in addition to receiving usual health care at the hospital. Quality of life and symptoms were measured by the FACT-G, cancer related fatigue by FACT-F and mood status by POMS. The inflammatory marker serum C-reactive protein (CRP) was also monitored serially. Results: Regression analysis indicated that the MQ intervention group significantly improved on measures of overall QOL (t144= -5.761, p<0.001), fatigue (t153= -5.621, p<0.001), mood disturbance (t122=2.346, p=0.021) and inflammation (CRP) (t99=2.042, p<0.044) compared to the usual care control group after controlling for baseline variables. Analysis of the FACT-G subscales revealed that the MQ intervention group also significantly improved in satisfaction with sex life (t92=-3.783, p<0.001) and reduced side effects of nausea (t152=-2.071, p=0.040) and sleep disturbance (t150=-2.603, p=0.010) compared to the usual care control group. Pain was improved in both intervention and control groups. Conclusions: This study suggests that MQ with usual health care can improve overall QOL, fatigue, positive mood status and reduce the side effects of nausea, sleep disturbance and inflammation of cancer patients. This study supports the use of MQ as an intervention for cancer care. No significant financial relationships to disclose.

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Effectiveness of community-based health education and home support program to reduce blood pressure among patients with uncontrolled hypertension in Nepal: A cluster-randomized trial

PLoS ONE ◽

10.1371/journal.pone.0258406 ◽

2021 ◽

Vol 16 (10) ◽

pp. e0258406

Author(s):

Mahesh Kumar Khanal ◽

Pratiksha Bhandari ◽

Raja Ram Dhungana ◽

Pratik Bhandari ◽

Lal B. Rawal ◽

...

Keyword(s):

Blood Pressure ◽

Health Education ◽

Usual Care ◽

Reduce Blood Pressure ◽

Uncontrolled Hypertension ◽

Control Group ◽

Community Based ◽

Home Support ◽

Cluster Randomized

Background Hypertension is a major global public health problem. Elevated blood pressure can cause cardiovascular and kidney diseases. We assessed the effectiveness of health education sessions and home support programs in reducing blood pressure among patients with uncontrolled hypertension in a suburban community of Nepal. Methods We conducted a community-based, open-level, parallel-group, cluster randomized controlled trial in Birendranagar municipality of Surkhet, Nepal. We randomly assigned four clusters (wards) into intervention and control arms. We provided four health education sessions, frequent home and usual care for intervention groups over six months. The participants of the control arm received only usual care from health facilities. The primary outcome of this study was the proportion of controlled systolic blood pressure (SBP). The analysis included all participants who completed follow-up at six months. Results 125 participants were assigned to either the intervention (n = 63) or the control (n = 62) group. Of them, 60 participants in each group completed six months follow-up. The proportion of controlled SBP was significantly higher among the intervention participants compared to the control (58.3% vs. 40%). Odds ratio of this was 2.1 with 95% CI: 1.01–4.35 (p = 0.046) and that of controlled diastolic blood pressure (DBP) was 1.31 (0.63–2.72) (p = 0.600). The mean change (follow-up minus baseline) in SBP was significantly higher in the intervention than in the usual care (-18.7 mmHg vs. -11.2 mmHg, p = 0.041). Such mean change of DBP was also higher in the intervention (-10.95 mmHg vs. -5.53 mmHg, p = 0.065). The knowledge score on hypertension improved by 2.38 (SD 2.4) in the intervention arm, which was significantly different from that of the control group, 0.13 (1.8) (p<0.001). Conclusions Multiple health education sessions complemented by frequent household visits by health volunteers can effectively improve knowledge on hypertension and reduce blood pressure among uncontrolled hypertensive patients at the community level in Nepal. Trial registration ClinicalTrial.gov: NCT02981251

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Abstract 3111: Contribution of Improved Cardiorespiratory Functions to Increased Pain-Free and Maximal Walking Distance in Patients with Claudication Following Arm Ergometer or Treadmill Exercise Training

Circulation ◽

10.1161/circ.116.suppl_16.ii_697-c ◽

2007 ◽

Vol 116 (suppl_16) ◽

Author(s):

Ulf G Bronas ◽

Diane Treat-Jacobson ◽

Arthur S Leon

Keyword(s):

Exercise Training ◽

Usual Care ◽

Treadmill Exercise ◽

Treadmill Training ◽

Walking Distance ◽

Control Group ◽

Supervised Exercise ◽

Ergometer Exercise ◽

Arm Ergometer ◽

Usual Care Control Group

Introduction: We previously reported that arm ergometer exercise training improves walking distance in patients with claudication similar to treadmill exercise training through unknown mechanisms. This is the first study to investigate the effects of 12 weeks of arm ergometer or treadmill training on cardiorespiratory functions during treadmill exercise testing in patients with claudication, as compared to a usual care control group. Hypothesis: Both arm ergometer and treadmill training will significantly improve cardiorespiratory functions, which will contribute to improvement in both pain-free walking distance (PFWD) and maximal walking distance (MWD). Methods: Participants (21m, 7f, mean age 65.6 yrs, 86 % smoke hx., 27% diabetes) with claudication were randomly assigned to supervised exercise training [arm ergometry (n=10) or treadmill (n=10) ] for 12 weeks, 3h/week, or to a usual care control group (n=8). Double product at stage 1 and at MWD, anaerobic threshold, and VO 2 at onset of claudication pain and VO 2 peak were assessed during a symptom-limited, graded treadmill exercise test. Changes in these functions from baseline were analyzed between groups via ANCOVA and associations between variables were determined by Pearson’s partial correlations. Results: Groups did not differ in baseline demographic, medical or exercise variables. There were significant differences in response of cardiorespiratory variables to training in both exercise groups compared to the control group, but no statistical differences between exercise groups. Significant moderate correlations were found between changes in all cardiorespiratory variables and changes in PFWD or MWD (Table 1 ). Conclusion: Improvements in cardiorespiratory functions following arm ergometer or treadmill training were significantly associated with changes in PFWD and MWD, supporting systemic contributions to exercise training-related improvements seen in patients with claudication. Changes from Baseline in Submaximal and Maximal Cardiorespiratory Variables and Walking Improvement

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Can Implementation of a Resilience Program for Primary School Children Enhance the Mental Health of Teachers?

Australian Journal of Guidance and Counselling ◽

10.1375/ajgc.19.2.116 ◽

2009 ◽

Vol 19 (2) ◽

pp. 116-130 ◽

Cited By ~ 9

Author(s):

Orla Tyson ◽

Clare M. Roberts ◽

Robert Kane

Keyword(s):

Mental Health ◽

Teacher Training ◽

Primary School ◽

Usual Care ◽

Primary Schools ◽

Primary School Children ◽

Control Group ◽

School Teachers ◽

Primary School Teachers ◽

Usual Care Control Group

AbstractThis study investigated whether a mental health promotion program delivered by primary school teachers to prevent internalising problems in children had any impact on the teachers' job-related affective wellbeing. Teacher job-related anxiety and job-related depression were measured before teaching the Aussie Optimism program, and after implementation at 12 and 24 months. Schools and teachers were randomised to one of three groups: Aussie Optimism with Teacher Training; Aussie Optimism with Teacher Training and Coaching; or the Usual Care control group, which implemented the regular Western Australian Health Education Curriculum. In all three groups, teachers taught lessons to promote student self-management and interpersonal skills during the last two years of primary school. Teachers in schools in the control group received training in Aussie Optimism after the first year of intervention. Data was collected from 405 primary school teachers in 63 government primary schools. Multiple hierarchical regression analyses showed partial support for the hypotheses, with teachers in the Training and Coaching intervention group reporting significantly lower levels of job-related anxiety at the 12-month assessment and depression at both the 12- and 24-month assessments when compared to teachers in the Usual Care control group. There were no significant differences between teachers in the Training only group and the control group after intervention.

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The WORD (Wholeness, Oneness, Righteousness, Deliverance): A Faith-Based Weight-Loss Program Utilizing a Community-Based Participatory Research Approach

Health Education & Behavior ◽

10.1177/1090198106291985 ◽

2006 ◽

Vol 35 (5) ◽

pp. 634-650 ◽

Cited By ~ 89

Author(s):

Karen Hye-cheon Kim ◽

Laura Linnan ◽

Marci Kramish Campbell ◽

Christine Brooks ◽

Harold G. Koenig ◽

...

Keyword(s):

Weight Loss ◽

African Americans ◽

Participatory Research ◽

Community Based Participatory Research ◽

Control Group ◽

Research Approach ◽

Community Based ◽

Faith Based ◽

Quasi Experimental ◽

Participatory Research Approach

Despite multidisciplinary efforts to control the nation's obesity epidemic, obesity has persisted as one of the U.S.'s top public health problems, particularly among African Americans. Innovative approaches to address obesity that are sensitive to the unique issues of African Americans are needed. Thus, a faith-based weight-loss intervention using a community-based participatory research approach was developed, implemented, and evaluated with a rural African American faith community. A two-group, quasi-experimental, delayed intervention design was used, with church as the unit of assignment (treatment n = 2, control n = 2) and individual as the unit of observation (treatment n = 36, control n = 37). Weekly small groups led by trained community members met for 8 weeks and emphasized healthy nutrition, physical activity, and faith's connection with health. The mean weight loss of the treatment group was 3.60 ± 0.64 lbs. compared to the 0.59 ± 0.59-lb loss of the control group.

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Empirically Derived Components of Hostility in a Community-Based Sample of African Americans

PsycEXTRA Dataset ◽

10.1037/e699602011-001 ◽

2011 ◽

Author(s):

Mana Ali ◽

Denee T. Mwendwa ◽

Regina C. Sims ◽

Serge Madhere ◽

Clive O. Callender ◽

...

Keyword(s):

African Americans ◽

Community Based

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Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

10.2196/preprints.13973 ◽

2019 ◽

Author(s):

Sarah Dineen-Griffin ◽

Victoria Garcia Cardenas ◽

Kylie Williams ◽

Shalom Isaac Benrimoj

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Self Care ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Community Pharmacies ◽

Randomized Controlled ◽

Minor Ailments ◽

Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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The Effect of Javanese Language Videos with a Community Based Interactive Approach Method as an Educational Instrument for Knowledge, Perception, and Adherence amongst Tuberculosis Patients

Pharmacy ◽

10.3390/pharmacy9020086 ◽

2021 ◽

Vol 9 (2) ◽

pp. 86

Author(s):

Fauna Herawati ◽

Yuni Megawati ◽

Aslichah ◽

Retnosari Andrajati ◽

Rika Yulia

Keyword(s):

Intervention Group ◽

Personal Control ◽

Control Group ◽

P Value ◽

Interactive Approach ◽

Community Based ◽

Tuberculosis Patients ◽

Level Of Knowledge ◽

The Impact

The long period of tuberculosis treatment causes patients to have a high risk of forgetting or stopping the medication altogether, which increases the risk of oral anti-tuberculosis drug resistance. The patient’s knowledge and perception of the disease affect the patient’s adherence to treatment. This research objective was to determine the impact of educational videos in the local language on the level of knowledge, perception, and adherence of tuberculosis patients in the Regional General Hospital (RSUD) Bangil. This quasi-experimental study design with a one-month follow-up allocated 62 respondents in the intervention group and 60 in the control group. The pre- and post-experiment levels of knowledge and perception were measured with a validated set of questions. Adherence was measured by pill counts. The results showed that the intervention increases the level of knowledge of the intervention group higher than that of the control group (p-value < 0.05) and remained high after one month of follow-up. The perceptions domains that changed after education using Javanese (Ngoko) language videos with the Community Based Interactive Approach (CBIA) method were the timeline, personal control, illness coherence, and emotional representations (p-value < 0.05). More than 95% of respondents in the intervention group take 95% of their pill compared to 58% of respondents in the control group (p-value < 0.05). Utilization of the local languages for design a community-based interactive approach to educate and communicate is important and effective.

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OP0198-HPR A STRUCTURED MODEL FOR OA CARE IN PRIMARY HEALTHCARE IS A COST-EFFECTIVE ALTERNATIVE COMPARED TO USUAL CARE FOR PEOPLE WITH HIP AND KNEE OA

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.950 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 119-120

Author(s):

N. Østerås ◽

E. Aas ◽

T. Moseng ◽

L. Van Bodegom-Vos ◽

K. Dziedzic ◽

...

Keyword(s):

Usual Care ◽

Primary Healthcare ◽

Intervention Group ◽

Cost Effective ◽

Cost Utility ◽

Control Group ◽

Structured Model ◽

Knee Oa ◽

Cost Effective Alternative ◽

The Cost

Background:To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international treatment recommendations. A previous analysis of a cluster RCT (cRCT) showed that compared to usual care, the intervention group reported higher quality of care and greater satisfaction with care. Also, more patients were treated according to international guidelines and fulfilled recommendations for physical activity at the 6-month follow-up.Objectives:To assess the cost-utility of a structured model for hip or knee OA care.Methods:A cRCT with stepped-wedge cohort design was conducted in 6 Norwegian municipalities (clusters) in 2015-17. The OA care model was implemented in one cluster at the time by switching from “usual care” to the structured model. The implementation of the model was facilitated by interactive workshops for general practitioners (GPs) and physiotherapists (PTs) with an update on OA treatment recommendations. The GPs explained the OA diagnosis and treatment alternatives, provided pharmacological treatment when appropriate, and suggested referral to physiotherapy. The PT-led patient OA education programme was group-based and lasted 3 hours followed by an 8–12-week individually tailored resistance exercise programme with twice weekly 1-hour supervised group sessions (5–10 patients per PT). An optional 10-hours Healthy Eating Program was available. Participants were ≥45 years with symptomatic hip or knee OA.Costs were measured from the healthcare perspective and collected from several sources. Patients self-reported visits in primary healthcare at 3, 6, 9 and 12 months. Secondary healthcare visits and joint surgery data were extracted from the Norwegian Patient Register. The health outcome, quality-adjusted life-year (QALY), was estimated based on the EQ-5D-5L scores at baseline, 3, 6, 9 and 12 months. The result of the cost-utility analysis was reported using the incremental cost-effectiveness ratio (ICER), defined as the incremental costs relative to incremental QALYs (QALYs gained). Based on Norwegian guidelines, the threshold is €27500. Sensitivity analyses were performed using bootstrapping to assess the robustness of reported results and presented in a cost-effectiveness plane (Figure 1).Results:The 393 patients’ mean age was 63 years (SD 9.6) and 74% were women. 109 patients were recruited during control periods (control group), and 284 patients were recruited during interventions periods (intervention group). Only the intervention group had a significant increase in EQ-5D-5L utility scores from baseline to 12 months follow-up (mean change 0.03; 95% CI 0.01, 0.05) with QALYs gained: 0.02 (95% CI -0.08, 0.12). The structured OA model cost approx. €301 p.p. with an additional €50 for the Healthy Eating Program. Total 12 months healthcare cost p.p. was €1281 in the intervention and €3147 in the control group, resulting in an incremental cost of -€1866 (95% CI -3147, -584) p.p. Costs related to surgical procedures had the largest impact on total healthcare costs in both groups. During the 12-months follow-up period, 5% (n=14) in the intervention compared to 12% (n=13) in the control group underwent joint surgery; resulting in a mean surgical procedure cost of €553 p.p. in the intervention as compared to €1624 p.p. in the control group. The ICER was -€93300, indicating that the OA care model resulted in QALYs gained and cost-savings. At a threshold of €27500, it is 99% likely that the OA care model is a cost-effective alternative.Conclusion:The results of the cost-utility analysis show that implementing a structured model for OA care in primary healthcare based on international guidelines is highly likely a cost-effective alternative compared to usual care for people with hip and knee OA. More studies are needed to confirm this finding, but this study results indicate that implementing structured OA care models in primary healthcare may be beneficial for the individual as well as for the society.Disclosure of Interests:None declared

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Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05228-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xin Ye ◽

Dawei Zhu ◽

Siyuan Chen ◽

Xuefeng Shi ◽

Rui Gong ◽

...

Keyword(s):

Quality Of Life ◽

Hearing Loss ◽

Cost Effectiveness ◽

Treatment Group ◽

Hearing Aids ◽

Control Group ◽

Chinese Adults ◽

Community Based ◽

The Impact

Abstract Background Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. Methods/design In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. Discussion The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. Trial registration Chinese Clinical Trial Registry ChiCTR1900024739. Registered on 26 July 2019.

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