scholarly journals Effects of an exercise and sport intervention among refugees living in a Greek refugee camp on mental health, physical fitness and cardiovascular risk markers: study protocol for the SALEEM pragmatic randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Markus Gerber ◽  
Flora Colledge ◽  
Dominique de Quervain ◽  
Konstantinia Filippou ◽  
Elsa Havas ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychiatric Disorders ◽  
Controlled Trial ◽  
Refugee Camp ◽  
Stress Disorders ◽  
Control Group ◽  
Physical Strain ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Wide Range

Abstract Background Due to ongoing political and social conflicts, the number of international refugees has been increasing. Refugees are exposed to severe mental and physical strain, as well as traumatic experiences during their flight. Therefore, the risk of psychiatric disorders is markedly increased among international refugees. International organizations have criticized the lack of early interventions as a key problem, because untreated mental disorders are often difficult to cure at a later stage. Today, exercise and sport have been successfully employed to treat a wide range of psychiatric disorders. With patients with post-traumatic stress disorders (PTSD), very limited empirical evidence exists, and studies carried out with international refugees are nearly non-existent. Methods We intend to implement a pragmatic randomized controlled trial (RCT) with an exercise and sport intervention group (n = 68, 50% women) and a wait-list control group (n = 68, 50% women) in the Koutsochero refugee camp, located close to the city of Larissa (Greece). During the RCT, exercise and sport will be offered five times per week (60 min/session) for 10 weeks. Participants will be asked to participate in at least two sessions per week. The programme is developed according to the participants’ needs and preferences and they will be able to choose between a range of activities. PTSD symptoms will serve as primary outcome, and several secondary outcomes will be assessed. Qualitative data collection methods will be used to gain a more in-depth appraisal of the participants’ perception of the intervention programme. In the second year of study, the programme will be opened to all camp residents. A strategy will be developed how the programme can be continued after the end of the funding period, and how the programme can be scaled up beyond the borders of the Koutsochero camp. Discussion By moving towards the primary prevention of chronic physical conditions and psychiatric disorders, a relevant contribution can be done to enhance the quality and quantity of life of refugee camp residents in Greece. Our findings may also strengthen the evidence for exercise as medicine as a holistic care option in refugee camps, by helping camp residents to adopt and maintain a physically active lifestyle. Trial registration The study was registered prospectively on the 8 February 2021 with ISRCTN https://www.isrctn.com/ISRCTN16291983

scholarly journals Thriving in adversity: Do brief milieu interventions work for young adults in the developing world? A pragmatic randomized controlled trial

2021 ◽  
Vol 49 (9) ◽  
pp. 1-8
Author(s):  
David Pearson ◽  
Fiona Clare Kennedy ◽  
Suchetha Bhat ◽  
Vishal Talreja ◽  
Katherine Newman-Taylor
Keyword(s):  
Randomized Controlled Trial ◽  
Life Skills ◽  
Controlled Trial ◽  
Control Group ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Socially Disadvantaged ◽  
Social Adversity ◽  
Age Range ◽  
The Impact

Adolescence may be a window of opportunity to attenuate the effects of early social adversity, which impedes cognitive, emotional, and social development, and increases risk of psychopathology into adulthood. We ran a pragmatic randomized controlled trial to assess the impact of a brief intervention designed to facilitate life skills for psychosocial competence. Socially disadvantaged young people living in South India who had experienced early adversity (N = 645; age range = 17–22 years) participated in the intervention or were assigned to a wait-list control group. The intervention led to large differences in life skills between the two groups. This brief, scalable intervention can be made available to address the impact of early social adversity on young people's development.

scholarly journals An evaluation of the efficacy of two add-on ecological momentary intervention modules for depression in a pragmatic randomized controlled trial (ZELF-i)

2020 ◽  
Author(s):  
Jojanneke A. Bastiaansen ◽  
Daan Alexander Ornée ◽  
Maaike Meurs ◽  
Albertine Oldehinkel
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Social Functioning ◽  
Controlled Trial ◽  
Control Group ◽  
Depression Treatment ◽  
Self Monitoring ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Ecological Momentary

Background Depression treatment might be enhanced by Ecological Momentary Interventions (EMI) based on self-monitoring and person-specific feedback. This study is the first to examine the efficacy of two different EMI modules for depression in routine clinical practice. MethodsOutpatients starting depression treatment at secondary mental health services (N = 161; MIDS-DEPRESSION = 35.9, SD = 10.7; MAGE = 32.8, SD = 12.1; 46% male) participated in a pragmatic randomized controlled trial with three arms. Two experimental groups engaged in 28 days of systematic self-monitoring (5 times per day), and received weekly feedback on either positive affect and activities (Do-module) or negative affect and thinking patterns (Think-module). The control group received no additional intervention. Participants completed questionnaires on depressive symptoms (primary outcome), social functioning, and empowerment before and after the intervention period, and at four measurements during a 6-month follow-up period. ResultsOf the 90 (out of 110) participants who completed the intervention, 86% would recommend it. However, the experimental groups did not show significantly more or faster changes over time than the control group in terms of depressive symptoms, social functioning and empowerment. Furthermore, trajectories of the two EMI modules were very similar. ConclusionsWe did not find statistical evidence that this type of EMI augments the efficacy of regular depression treatment, regardless of module content. We cannot rule out that EMIs have a positive impact on other domains or provide a more efficient way of delivering care. Nonetheless, EMI’s promise of effectiveness has not materialized yet.

Electroconvulsive therapy (ECT) for treating agitation in dementia (major neurocognitive disorder) – a promising option

2017 ◽  
Vol 29 (5) ◽  
pp. 717-726 ◽  
Author(s):  
Oliver M. Glass ◽  
Brent P. Forester ◽  
Adriana P. Hermida
Keyword(s):  
Randomized Controlled Trial ◽  
Electroconvulsive Therapy ◽  
Rating Scales ◽  
Controlled Trial ◽  
Case Series ◽  
Small Sample ◽  
Control Group ◽  
Neurocognitive Disorder ◽  
Randomized Controlled ◽  
Wide Range

ABSTRACTBackground:Agitation in patients with dementia increases caretaker burden, increases healthcare costs, and worsens the patient's quality of life. Antipsychotic medications, commonly used for the treatment of agitation in patients with dementia have a box warning from the FDA for elevated mortality risk. Electroconvulsive therapy (ECT) has made significant advances over the past several years, and is efficacious in treating a wide range of psychiatric conditions. We provide a systematic review of published literature regarding the efficacy of ECT for the treatment of agitation in patients with dementia (major neurocognitive disorder).Methods:We searched PubMed, Medline, Google Scholar, UptoDate, Embase, and Cochrane for literature concerning ECT for treating agitation in dementia using the title search terms “ECT agitation dementia;” “ECT aggression dementia;” “ECT Behavior and Psychological Symptoms of Dementia;” and “ECT BPSD.” The term “dementia” was also interchanged with “Major Neurocognitive Disorder.” No time frame restriction was placed. We attempted to include all publications that were found to ensure a comprehensive review. We found 11 papers, with a total (N) of 216 patients.Results:Limited to case reports, case series, retrospective chart review, retrospective case-control, and an open label prospective study, ECT has demonstrated promising results in decreasing agitation in patients with dementia. Patients who relapsed were found to benefit from maintenance ECT.Conclusions:Available studies are often limited by concomitant psychotropic medications, inconsistent use of objective rating scales, short follow-up, lack of a control group, small sample sizes, and publication bias. A future randomized controlled trial will pose ethical and methodological challenges. A randomized controlled trial must carefully consider the definition of usual care as a comparison group. Well-documented prospective studies and/or additional case series with explicit selection criteria, a wide range of outcome measures, and less selection bias of the study sample that may favor treatment response, is warranted. ECT may be a promising option for the treatment of aggression and agitation in patients with severe dementia who are refractory to other treatment options, but the limitations of available studies suggest that a cautious approach to future randomized controlled trials is warranted.

scholarly journals An evaluation of the efficacy of two add-on ecological momentary intervention modules for depression in a pragmatic randomized controlled trial (ZELF-i)

2020 ◽  
pp. 1-10
Author(s):  
Jojanneke A. Bastiaansen ◽  
Daan A. Ornée ◽  
Maaike Meurs ◽  
Albertine J. Oldehinkel
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Social Functioning ◽  
Controlled Trial ◽  
Control Group ◽  
Depression Treatment ◽  
Self Monitoring ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Ecological Momentary

Abstract Background Depression treatment might be enhanced by ecological momentary interventions (EMI) based on self-monitoring and person-specific feedback. This study is the first to examine the efficacy of two different EMI modules for depression in routine clinical practice. Methods Outpatients starting depression treatment at secondary mental health services (N = 161; MIDS−DEPRESSION = 35.9, s.d. = 10.7; MAGE = 32.8, s.d. = 12.1; 46% male) participated in a pragmatic randomized controlled trial with three arms. Two experimental groups engaged in 28 days of systematic self-monitoring (5 times per day), and received weekly feedback on either positive affect and activities (Do-module) or negative affect and thinking patterns (Think-module). The control group received no additional intervention. Participants completed questionnaires on depressive symptoms (primary outcome), social functioning, and empowerment before and after the intervention period, and at four measurements during a 6-month follow-up period. Results Of the 90 (out of 110) participants who completed the intervention, 86% would recommend it. However, the experimental groups did not show significantly more or faster changes over time than the control group in terms of depressive symptoms, social functioning, and empowerment. Furthermore, the trajectories of the two EMI modules were very similar. Conclusions We did not find statistical evidence that this type of EMI augments the efficacy of regular depression treatment, regardless of module content. We cannot rule out that EMIs have a positive impact on other domains or provide a more efficient way of delivering care. Nonetheless, EMI's promise of effectiveness has not materialized yet.

scholarly journals Thriving in adversity: Do life skills programs work for developing world children? A pragmatic randomized controlled trial

2021 ◽  
Vol 49 (9) ◽  
pp. 1-13
Author(s):  
David Pearson ◽  
Fiona Clare Kennedy ◽  
Vishal Talreja ◽  
Suchetha Bhat ◽  
Katherine Newman-Taylor
Keyword(s):  
Randomized Controlled Trial ◽  
Life Skills ◽  
Developing World ◽  
Controlled Trial ◽  
Social Impairment ◽  
Control Group ◽  
Conflict Zones ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
The Impact

The severe adversity experienced by millions of children in the developing world leads to failure to thrive associated with cognitive deficits, emotional management problems, and social impairment. In this pragmatic randomized controlled trial, 909 children (aged 8–15 years) in India with disadvantaged backgrounds took part in a semistructured program involving sports or creative arts activities. The Life Skills Assessment Scale was used to assess the children's life skills before and after taking part in the program. Children who took part in the program showed significant increases in life skills following participation, compared to a control group. This study demonstrates the impact of simple, low-budget programs on cognitive, emotional, and social life skills that are typically delayed by severe adversity. The findings have clear implications for children in other adverse environments, such as conflict zones and settlements for displaced children resulting from war, natural disasters, and emergency events.

scholarly journals Self-administration of medication: a pragmatic randomized controlled trial of the impact on dispensing errors, perceptions, and satisfaction

2020 ◽  
Vol 11 ◽  
pp. 204209862090461 ◽  
Author(s):  
Charlotte Arp Sørensen ◽  
Marianne Lisby ◽  
Charlotte Olesen ◽  
Ulrika Enemark ◽  
Signe Bredsgaard Sørensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Medication List ◽  
Self Administration ◽  
Participant Satisfaction ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Dispensing Errors

Background: Our aim was to investigate whether self-administration of medication (SAM) during hospitalization affects the number of dispensing errors, perceptions regarding medication, and participant satisfaction when compared with nurse-led medication dispensing. Methods: A pragmatic randomized controlled trial was performed in a Danish cardiology unit. Patients aged ⩾ 18 years capable of SAM were eligible for inclusion. Patients were excluded if they did not self-administer medication at home, were not prescribed medication suitable for self-administration, or did not speak Danish. Intervention group participants self-administered their medication. In the control group, medication was dispensed and administered by nurses. The primary outcome was the proportion of dispensing errors collected through modified disguised observation of participants and nurses. Dispensing errors were divided into clinical and procedural errors. Secondary outcomes were explored through telephone calls to determine participant perceptions regarding medication and satisfaction, and finally, deviations in their medication list two weeks after discharge. Results: Significantly fewer dispensing errors were observed in the intervention group, with 100 errors/1033 opportunities for error (9.7%), compared with 132 errors/1028 opportunities for error (12.8%) in the control group. The number of clinical errors was significantly reduced, whereas no difference in procedural errors was observed. At follow up, those who were self-administering medication had fewer concerns regarding their medication, found medication to be less harmful, were more satisfied, preferred this opportunity in the future, and had fewer deviations in their medication list after discharge compared with the control group. Conclusion: In conclusion, the reduced number of dispensing errors in the intervention group, indicate that SAM is safe. In addition, SAM had a positive impact on (a) perceptions regarding medication, thus suggesting increased medication adherence, (b) deviations in medication list after discharge, and (c) participant satisfaction related to medication management at the hospital.

scholarly journals Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI): Protocol for a Pragmatic Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Hayford M Avedzi ◽  
Kate Storey ◽  
Jeffrey A Johnson ◽  
Steven T Johnson
Keyword(s):  
Randomized Controlled Trial ◽  
Healthy Eating ◽  
Glycemic Index ◽  
Controlled Trial ◽  
Control Group ◽  
Evidence Based ◽  
Active Living ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Phone Calls

BACKGROUND Rigorous evidence is needed regarding the best approach for increasing the uptake of Diabetes Canada’s evidence-based recommendations to include low-glycemic index (GI) foods in daily meal planning as an effective dietary self-care strategy for glycemic control among people with type 2 diabetes (T2D). OBJECTIVE This study aims to present the study design and baseline data from the Healthy Eating and Active Living for Diabetes-Glycemic Index (HEALD-GI) trial, which was designed to evaluate the effectiveness of an enhanced GI-targeted nutrition education on GI-related knowledge and mean daily GI among adults with T2D in Edmonton, Alberta. METHODS We used a pragmatic randomized controlled trial design and allocated 67 adults (aged ≥18 years) with T2D living in Edmonton, Alberta, Canada, to a control group that received standard printed copies of Canada’s Food Guide and Diabetes Canada’s GI resources or to an intervention group that received the same materials, plus a customized Web-based platform with 6 self-directed learning modules and print material. Each module included videos, links to reliable websites, chat rooms, and quizzes. Evidence-based GI concept information included GI values of foods and low-GI shopping, recipes, and cooking tips by a registered dietitian. In addition, support through email, text messaging (short message service), phone calls, or postal mail was provided to reinforce participants’ learning. The primary outcome, average dietary GI, was assessed using 3-day food records. Additional measures including GI knowledge and self-efficacy, glycated hemoglobin (HbA1c), lipids, systolic blood pressure, body mass index (BMI; weight, height), waist circumference, and computer proficiency were assessed at baseline and at 3-month postintervention. RESULTS Between November 2017 and February 2018, we contacted adults (aged ≥18 years) with T2D living in Edmonton, Alberta, screened and recruited eligible participants into the study. All data collection ended in June 2018. Overall, 64% (43/67) participants were males; mean age was 69.5 (SD 9.3) years, with a mean diabetes duration of 19.0 (SD 13.7) years. Mean BMI was 30.1 (SD 5.7) kg/m2, and mean HbA1c value was 7.1% (SD 1.2%). Data analysis was completed in December 2018. CONCLUSIONS The GI concept is often difficult to teach. The HEALD-GI study aims to provide evidence in support of an alternative approach to translating the GI concept to adults with T2D. Findings from this study may help registered dietitians to better disseminate low-GI dietary recommendations using efficient and cost-effective, patient-centered approaches. Furthermore, evidence generated will contribute to addressing some of the controversies regarding the clinical usefulness of the GI concept. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11707

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)

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.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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