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

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

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18063097 ◽

2021 ◽

Vol 18 (6) ◽

pp. 3097

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, 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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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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SleepSure: a pilot randomized-controlled trial to assess the effects of eye masks and earplugs on the quality of sleep for patients in hospital

Clinical Rehabilitation ◽

10.1177/0269215518806041 ◽

2018 ◽

Vol 33 (2) ◽

pp. 253-261 ◽

Cited By ~ 6

Author(s):

Samaher Sweity ◽

Andrew Finlay ◽

Charlotte Lees ◽

Adam Monk ◽

Toshi Sherpa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Length Of Stay ◽

Sleep Quality ◽

Controlled Trial ◽

Intervention Group ◽

Recruitment Rate ◽

Control Group ◽

Inpatient Stay ◽

Open Label ◽

Randomized Controlled

Objective: To determine the short-term effects of supplying hospital inpatients with earplugs and eye masks, preparatory to a full-scale trial. Design: A single-centre, open-label, two-arm, parallel group, randomized-controlled trial. Setting: A total of 13 medical and surgical wards in a large teaching hospital in the United Kingdom. Participants: Everyone admitted to hospital aged 18 years or older, who stayed overnight and had the mental capacity and sufficient understanding of English to give consent, the ability to complete the study questionnaire and the ability to use earplugs and eye masks unaided was considered. Interventions: The intervention group was provided with earplugs and eye masks for use the following night, and the control group received standard care. Main measures: Sleep quality assessed using the SleepSure questionnaire after the first night of using the intervention, use of earplugs and eye masks, number of falls throughout their inpatient stay, use of zopiclone during inpatient stay, length of stay and recruitment rate. Results: A total of 1600 patients were admitted; out of which, 626 (39%) were eligible and 206 (13% total, 33% eligible) recruited (intervention group, 109). The intervention group’s mean sleep quality score was 6.33 (95% confidence interval (CI): 5.89–6.77), compared with 5.09 (95% CI: 4.66–5.52) in the control group ( p < 0.001). There were no differences in use of zopiclone, falls or length of stay between the groups. Of the intervention group, 91 (86%) reported using the earplugs and/or eye masks. Conclusions: The intervention seems feasible, and effective, but trial eligibility rate and rate of recruitment into the study were limited.

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A Web-Based Multidomain Lifestyle Intervention for Older Adults: The eMIND Randomized Controlled Trial

Journal of Prevention of Alzheimer's Disease ◽

10.14283/jpad.2020.70 ◽

2020 ◽

pp. 1-9 ◽

Cited By ~ 1

Author(s):

P. de Souto Barreto ◽

K. Pothier ◽

G. Soriano ◽

M. Lussier ◽

L. Bherer ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Structured Interviews ◽

Subjective Memory ◽

Web Based ◽

Randomized Controlled

Importance/Objective: To describe the feasibility and acceptability of a 6-month web-based multidomain lifestyle training intervention for community-dwelling older people and to test the effects of the intervention on both function- and lifestyle-related outcomes. Design: 6-month, parallel-group, randomized controlled trial (RCT). Setting: Toulouse area, South-West, France. Participants: Community-dwelling men and women, ≥ 65 years-old, presenting subjective memory complaint, without dementia. Intervention: The web-based multidomain intervention group (MIG) received a tablet to access the multidomain platform and a wrist-worn accelerometer measuring step counts; the control group (CG) received only the wrist-worn accelerometer. The multidomain platform was composed of nutritional advices, personalized exercise training, and cognitive training. Main outcomes and measures: Feasibility, defined as the proportion of people connecting to ≥75% of the prescribed sessions, and acceptability, investigated through content analysis from recorded semi-structured interviews. Secondary outcomes included clinical (eg, cognitive function, mobility, health-related quality of life (HRQOL)) and lifestyle (eg, step count, food intake) measurements. Results: Among the 120 subjects (74.2 ±5.6 years-old; 57.5% women), 109 completed the study (n=54, MIG; n=55, CG). 58 MIG subjects connected to the multidomain platform at least once; among them, adherers of ≥75% of sessions varied across multidomain components: 37 people (63.8% of 58 participants) for cognitive training, 35 (60.3%) for nutrition, and three (5.2%) for exercise; these three persons adhered to all multidomain components. Participants considered study procedures and multidomain content in a positive way; the most cited weaknesses were related to exercise: too easy, repetitive, and slow progression. Compared to controls, the intervention had a positive effect on HRQOL; no significant effects were observed across the other clinical and lifestyle outcomes. Conclusions and Relevance: Providing multidomain lifestyle training through a web-platform is feasible and well-accepted, but the training should be challenging enough and adequately progress according to participants’ capabilities to increase adherence. Recommendations for a larger on-line multidomain lifestyle training RCT are provided.

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