Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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Community Health Workers as a Strategy to Tackle Psychosocial Suffering due to Physical Distancing: A Randomized Controlled Trial

10.20944/preprints202103.0097.v1 ◽

2021 ◽

Author(s):

Dorien Vanden Bossche ◽

Susan Lagaert ◽

Sara Willems ◽

Peter Decat

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Health Workers ◽

Psychosocial Support ◽

Controlled Trial ◽

Intervention Group ◽

Psychosocial Health ◽

Control Group ◽

Randomized Controlled ◽

The Impact

Background: During the COVID-19 pandemic some family physicians were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psycho-social support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW in-terventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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The Impact of Implementing Steps of Empowerment Model on Decisional Conflict for Re-Pregnancy for Women with Failed Pregnancies: A Randomized Controlled Trial

10.53350/pjmhs211551604 ◽

2021 ◽

Vol 15 (5) ◽

pp. 1604-1615

Author(s):

Mozhgan Zareyee Salehabadi ◽

Masoomeh Kheirkhah ◽

Nazanin Esmaeeli ◽

Shima Haghani

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Decisional Conflict ◽

Control Group ◽

Random Allocation ◽

Decision Conflict ◽

Randomized Controlled ◽

Empowerment Model ◽

The Impact

Background: Failed pregnancy is known as a common and destructive experience. It has physical and psychological effects on both women and their families. Due to this experience, they may become reluctant to be pregnant again. In this regard, providing the coping strategies can help in being adapted to failed pregnancies, and making informed decisions on future pregnancies. So, this study was designed and then performed to determine the effect of implementing steps of empowerment model on decision conflict for re-pregnancy for women with failed pregnancies Method: This interventional research was a randomized controlled trial with a control group conducted in Iran from January 2020 to May 2020. Participants were 80 women who had been hospitalized in a referral center during the past 3-6 weeks due to failed pregnancies. Afterward, the eligible women were divided into the two groups of intervention (n=40) and control (n=40) with random allocation of sealed envelope site and a separate code was then determined for each person. The intervention was performed in four sessions lasted for 90-minute based on the model steps (threat perception, problem solving, educational participation, and evaluation) for intervention group. O'Connor's decisional conflict scale was completed in both groups once before and once six weeks after intervention. The obtained data were analyzed using SPSS edition 16 with the independent T-test, Fisher, and chi-squared tests. Results The scores of decisional conflict and its subscales had no differences between the two groups before the intervention (P = 0.65). However, by passing six weeks from the intervention, the decisional conflict and all its subscales have reduced in the intervention group. (P < 0.001). Conclusion: Empowerment education in women with failed pregnancies improved their decision conflict in immune re-pregnancy, so empowerment education along with health care services is recommended for women with failed pregnancies. Trial registration: This randomized control trial was registered on the TCTR site with the code TCTR20191226001. Registered on 26 December 2019. https://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=5336 Keywords: Empowerment, Conflict, Decision Making, Failed Pregnancy.

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Nutrition information system (SISFORNUTRIMIL) application With Online Food Record for Indonesia Pregnant Women: Protocol for Randomized Controlled Trial

10.21203/rs.3.rs-634069/v1 ◽

2021 ◽

Author(s):

Mira Trisyani Koeryaman ◽

Saseendran Pallikadavath ◽

Isobel Ryder ◽

Ngianga Kandala

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Dietary Diversity ◽

Controlled Trial ◽

Intervention Group ◽

Eating Behaviour ◽

Control Group ◽

Food Record ◽

Randomized Controlled ◽

The Impact

Abstract Background: The pregnant women and family may not have the necessary knowledge and skills to estimate nutrient value in food in line with dietary targets and the guidelines, i.e. they do not know whether or not they are consuming the right amount of nutrition needed during pregnancy. The aims of this randomized controlled trial (RCT) is to examine the impact of SISFORNUTRIMIL application on maternal eating behaviour and associated maternal factors such as weight gain, blood pressure, biochemical measurement, and pregnancy outcome.Methods: The study recruits 112 participants with eligible criteria during December 2019 to January 2020. The allocation of participants is 1:1 to the SISFORNUTRIMIL application user and non-user application, with criteria: singleton pregnancy (22-26 weeks), mother age between 20-35 years), have monthly income and literate. Both groups will receive 12-week standard health services from health professionals and received information about dietary diversity and food record. Particularly, intervention group could be access the SISFORNUTRIMIL on their devices, which provide necessary information about nutrition in pregnancy, food record and food choice includes total serving size calculation. In contrast, the control group only receive food information and food intake record by paper-based, and they should record and calculate the nutrition intake by traditionally. Discussion: This is the first randomized controlled trial to examine the SISFORNUTIMIL application. This mandate reflects keen interest and motivation for the proposed research study. This is in addition to the researcher’s personal efforts to reduce morbidity and mortality rate as well as a general focus on pregnancy complication prevention than nutrition treatment. Thus, an investigation of eating behaviour and associated maternal needed to address this issue. Firstly, the results could extend the scope of knowledge about nutrition intervention to include the Indonesia pregnant women context as well as the Indonesia health ministry context. Secondly, this research could help to change individual health behaviour and activity undertaken by an individual who believes her-self to be healthy.Trial registration: ISRCTN Registry: ISRCTN42690828. Date of registration: 22 October 2019.

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The Impact of Implementing Steps of Empowerment Model for Women with Failed Pregnancies on Decisional Conflict for Re-pregnancy: A Randomized Controlled Trial

10.21203/rs.3.rs-34460/v1 ◽

2020 ◽

Author(s):

Masoomeh Kheirkhah ◽

Mozhgan Zareyee Salehabadi ◽

Nazanin Esmaeeli ◽

Shima Haghani

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Decisional Conflict ◽

Control Group ◽

Random Allocation ◽

Decision Conflict ◽

Randomized Controlled ◽

Empowerment Model ◽

The Impact

Abstract Background: Failed pregnancy is a common and destructive experience. It has physical and psychological effects on both women and families. They may become reluctant to re-pregnancy. Providing the coping strategies can help to adapt to failed pregnancies, and make informed decisions about future pregnancies. This study was designed and performed to determine the effect of implementing steps of empowerment model for women with failed pregnancies on decision conflict for re-pregnancy. Method: This interventional research is a randomized controlled trial with a control group that was conducted in Iran from January 2020 to May 2020. Participants were 80 women who had been hospitalized in a referral center during past 3-6 weeks due to failed pregnancies. The eligible women with random allocation of sealed envelope site were divided into two groups of intervention (n=40) and control (n=40) and a separate code was determined for each person. The intervention was performed in four, 90-minute sessions based on the model steps (threat perception, problem solving, educational participation, and evaluation) for intervention group. O'Connor's decisional conflict scale was completed before and six weeks after intervention by both of groups. Data were analyzed using SPSS edition 16 with the independent T-test, Fisher and chi-squared tests. Results: The score of decisional conflict and, its subscales did not differ between the two groups before the intervention (P = 0.65), but six weeks after the intervention, the decisional conflict and, all its subscales in the intervention group reduced. (P < 0.001).Conclusion: Empowerment education in women with a failed pregnancy improved their decision conflict in re-pregnancy, so empowerment education along with health care services for women with failed pregnancies is recommended. Trial registration: This randomized control trial was registered on the TCTR site with the code TCTR20191226001. Registered on 26 December 2019.

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A Randomized Controlled Trial of the Impact of a Teaching Procedure Service on the Training of Internal Medicine Residents

Journal of Graduate Medical Education ◽

10.4300/jgme-d-11-00136.1 ◽

2012 ◽

Vol 4 (2) ◽

pp. 170-175 ◽

Cited By ~ 10

Author(s):

Michelle Mourad ◽

Sumant Ranji ◽

Diane Sliwka

Keyword(s):

Internal Medicine ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

First Year ◽

Randomized Controlled ◽

Teaching Procedure ◽

Viable Solution ◽

The Impact

Abstract Introduction Academic medical centers must provide safe inpatient procedures while balancing resident autonomy and education. We performed a randomized, controlled trial to evaluate the effect of a 2-week hospitalist procedure service (HPS) rotation on interns' self-perceived procedure ability, knowledge, and autonomy versus the standard curriculum. Methods We randomly selected 16 of 57 internal medicine interns (28%) to participate in the intervention group rotation, with 29 interns in the control group. All interns were surveyed before the start of residency and at the end of the postgraduate year-1 (PGY-1) and PGY-2 years to evaluate self-reported knowledge and ability to (1) safely perform procedures, (2) supervise procedures, and (3) use bedside ultrasound. Results Ninety-four percent of HPS interns (15/16) and 71% of control interns (29/41) completed all surveys. Baseline knowledge and experience did not differ significantly between the groups. The intervention group performed significantly more paracentesis (9 versus 4; P < .001), thoracentesis (6 versus 2; P < .001), and lumbar puncture (4 versus 3; P < .001) procedures than did the control group. After their first year, residents who completed the HPS rotation rated their ability to safely perform and supervise all of the assessed procedures as higher (P < .05 for all procedures) and were more likely to rate self-perceived knowledge as very good or excellent in all surveyed aspects of procedure performance (P < .05). Discussion A 2-week hospitalist-supervised procedure service rotation substantially improved residents' experience, confidence, and knowledge in performing bedside procedures early in their training, with this effect sustained through the PGY-2 year. Standardized procedure service rotations are a viable solution for programs seeking to improve their procedure-based education.

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Effect of Contextualized Versus Non-Contextualized Interventions for Improving Hand Washing, Sanitation, and Health in Rural Tanzania: Study Design of a Cluster Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16142529 ◽

2019 ◽

Vol 16 (14) ◽

pp. 2529 ◽

Cited By ~ 1

Author(s):

Kim Dockx ◽

Hans Van Remoortel ◽

Emmy De Buck ◽

Charlotte Schelstraete ◽

An Vanderheyden ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomized Controlled Trial ◽

Hand Washing ◽

Control Group ◽

Randomized Controlled ◽

Rural Tanzania ◽

Cluster Randomized ◽

The Impact

Nearly 90% of diarrhea-related mortalities are the result of unsafe drinking water, poor sanitation, and insufficient hygiene. Although “Water, Sanitation, and Hygiene” (WASH) interventions may significantly reduce the risk of diarrheal disease, it is currently unclear which interventions are the most effective. In this study, we aim to determine the importance of contextualizing a WASH intervention to the local context and the needs for increasing impact (Clinicaltrials.gov NCT03709368). A total of 1500 households in rural Tanzania will participate in this cluster randomized controlled trial. Households will be randomized into one of three cohorts: (1) a control group receiving a basic intervention and 1 placebo household visit, (2) an intervention group receiving a basic intervention + 9 additional household visits which are contextualized to the setting using the RANAS approach, and (3) an intervention group receiving a basic intervention + 9 additional household visits, which are not contextualized, i.e., a general intervention. Assessments will take place at a baseline, 1 and 2 years after the start of the intervention, and 1 year after the completion of the intervention. Measurements involve questionnaires and spot checks. The primary outcome is hand-washing behavior, secondary objectives include, the impact on latrine use, health, WASH infrastructure, quality of life, and cost-effectiveness.

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The effect of eggs on early child growth in rural Malawi: the Mazira Project randomized controlled trial

American Journal of Clinical Nutrition ◽

10.1093/ajcn/nqz163 ◽

2019 ◽

Vol 110 (4) ◽

pp. 1026-1033 ◽

Cited By ~ 10

Author(s):

Christine P Stewart ◽

Bess Caswell ◽

Lora Iannotti ◽

Chessa Lutter ◽

Charles D Arnold ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Head Circumference ◽

Controlled Trial ◽

Intervention Group ◽

Child Growth ◽

Control Group ◽

Z Score ◽

Randomized Controlled ◽

The Impact

ABSTRACT Background Stunted growth is a significant public health problem in many low-income countries. Objective The aim of this study was to evaluate the impact of 1 egg per day on child growth in rural Malawi. Design We conducted an individually randomized controlled trial in which 660 children aged 6–9 mo were equally allocated into an intervention (1 egg/d) or control group. Eggs were provided during twice-weekly home visits for 6 mo. Control households were visited at the same frequency. Assessors blinded to intervention group measured length, weight, head circumference, and midupper arm circumference at baseline and the 6-mo follow-up visit. To assess adherence, multipass 24-h dietary recalls were administered at baseline, 3-mo, and 6-mo visits. Results Between February and July 2018, 660 children were randomly assigned into the intervention (n = 331) and control (n = 329) groups. Losses to follow-up totaled 10%. In the intervention group, egg consumption increased from 3.9% at baseline to 84.5% and 70.3% at the 3-mo and 6-mo visits, whereas in the control group, it remained below 8% at all study visits. The baseline prevalence of stunting was 14%, underweight was 8%, and wasting was 1% and did not differ by group. There was no intervention effect on length-for-age, weight-for-age, or weight-for-length z scores. There was a significantly higher head circumference for age z score of 0.18 (95% CI: 0.01, 0.34) in the egg group compared with the control group. There was a significant interaction with maternal education (P = 0.024), with an effect on length-for-age z score only among children whose mothers had higher education. Conclusions The provision of 1 egg per day to children in rural Malawi had no overall effect on linear growth. A background diet rich in animal source foods and low prevalence of stunting at baseline may have limited the potential impact. This trial was registered at clinicaltrials.gov as NCT03385252.

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The Impact of Umbilical Cord Clamping Time on the Infant Anemia: A Randomized Controlled Trial

Iranian Journal of Public Health ◽

10.18502/ijph.v50i5.6116 ◽

2021 ◽

Author(s):

Sevil Güner ◽

Birsen Karaca Saydam

Keyword(s):

Randomized Controlled Trial ◽

Umbilical Cord ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Cord Clamping ◽

Significant Difference ◽

Umbilical Cord Clamping ◽

The Impact

Background: Anemia during infancy causes irreversible physical, cognitive, motor, and behavioral development disorders. This study aimed to determine the effect of delaying umbilical cord clamping time on certain parameters regarding anemia during the infancy. Methods: This randomized controlled trial was conducted at a university hospital in west of Turkey (Dec 2017- Dec 2018). Overall, 110 participants were evaluated for the research, 65 participants were randomized after excluding those who did not meet the inclusion criteria (intervention=32, control=33). Randomly assigned to delayed clamping (1 min after delivery) or early clamping (in 15 sec after delivery), and followed up until 4 months postpartum. 48th-hour hematocrit, bilirubin values, need for phototherapy and hematocrit, hemoglobin values, diagnosis of anemia at the postnatal fourth month were compared between two groups. The data showing normal distribution were assessed using the parametric tests. The level of statistical significance was determined as P<0.05. Results: The 48th-hour hematocrit and bilirubin levels of the intervention group were significantly higher than the control (P<0.01 and P<0.05, respectively). No significant difference regarding the need for phototherapy due to postnatal hyperbilirubinemia was observed between the two groups (P>0.05). Means of the intervention group hematocrit and hemoglobin levels measured during anemia screening performed at the fourth month were found to be higher than those of the infants in the control group (P<0.05 and P<0.05, respectively). Conclusion: Delaying umbilical cord clamping had a positive impact on the haematological parameters of infants. Clamping the cord at least one minute in birth can be performed to prevent the iron deficit anemia that could be seen during the first years of infants’ lives.

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

10.2196/preprints.16141 ◽

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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