scholarly journals Depression education fotonovela for engagement of Hispanic patients in treatment: a randomized clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Katherine Sanchez ◽  
Brittany H. Eghaneyan ◽  
Michael O. Killian ◽  
Leopoldo J. Cabassa ◽  
Madhukar H. Trivedi
Keyword(s):  
Clinical Trial ◽  
Patient Education ◽  
Integrated Care ◽  
Randomized Clinical Trial ◽  
Education Intervention ◽  
Link Type ◽  
Hispanic Patients ◽  
Depression Education ◽  
Education Groups ◽  
Over Time

Abstract Background We report the primary outcomes from a randomized clinical trial testing a novel culturally-adapted patient education intervention to increase engagement of Hispanic patients in depression treatment. The Depression Education Fotonovela (DEF), Secret Feelings, incorporates popular images, cultural norms, and vivid pictures embedded within a soap opera narrative to increase depression knowledge and dispel myths about treatment. We then assessed engagement in a integrated care treatment model in response to the education intervention and subsequent changes in depression symptoms in a large community-based clinic whose patient population is majority Hispanic. Method The sample included 150 adult Hispanic patients with a confirmed diagnosis of depression who were randomly assigned to either: [1] integrated care + fotonovela; or [2] integrated care + standard education. Differences between treatment groups were examined as were changes in depression, anxiety, depression knowledge, and stigma scores over time and engagement in treatment. Results Results indicated that while depression scores significantly decreased over time for participants (F [2.811, 416.054] = 197.69, p < .001, η2 = .572), no differences between the two education groups were found (F [1, 148] = 0.70, p = .403, η2 = .005). At 12-month follow-up, 101 patients (80.8%) reported a 50% of greater reduction in depression scores from baseline. Conclusions We found little difference between the two education groups, suggesting that either may helpful for engaging Hispanic patients into care. Better tailoring of patient education, with the fotonovela or similarly adapted tools, will require more directly addressing the stigma associated with antidepressant medication. Trial registration The study was registered with www.clinicaltrials.gov: NCT02702596, on 03/20/2016. Retrospectively registered.

scholarly journals Depression Education Fotonovela for Engagement of Hispanic Patients in Treatment: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Katherine Sanchez ◽  
Brittany H. Eghaneyan ◽  
Michael O. Killian ◽  
Leopoldo J. Cabassa ◽  
Madhukar H. Trivedi
Keyword(s):  
Clinical Trial ◽  
Patient Education ◽  
Integrated Care ◽  
Randomized Clinical Trial ◽  
Depression Symptoms ◽  
Education Intervention ◽  
Hispanic Patients ◽  
Depression Education ◽  
Education Groups ◽  
Over Time

Abstract Background We report the primary outcomes from a randomized clinical trial testing a novel culturally-adapted patient education intervention to increase engagement of Hispanic patients in depression treatment. The Depression Education Fotonovela (DEF), Secret Feelings, incorporates popular images, cultural norms, and vivid pictures embedded within a soap opera narrative to increase depression knowledge and dispel myths about treatment. We then assessed engagement in a integrated care treatment model in response to the education intervention and subsequent changes in depression symptoms in a large community-based clinic whose patient population is majority Hispanic.Method The sample included 150 adult Hispanic patients with a confirmed diagnosis of depression who were randomly assigned to either: (1) integrated care + fotonovela; or (2) integrated care + standard education. Differences between treatment groups were examined as were changes in depression, anxiety, depression knowledge, and stigma scores over time and engagement in treatment.Results Results indicated that while depression scores significantly decreased over time for participants (F [2.811, 416.054] = 197.69, p < .001, 𝜂2 = .572), no differences between the two education groups were found (F [1, 148] = 0.70, p = .403, 𝜂2 = .005). At 12-month follow-up, 101 patients (80.8%) reported a 50% of greater reduction in depression scores from baseline.Conclusions We found little difference between the two education groups, suggesting that either may helpful for engaging Hispanic patients into care. Better tailoring of patient education, with the fotonovela or similarly adapted tools, will require more directly addressing the stigma associated with antidepressant medication.Trial registrationThe study was registered with www.clinicaltrials.gov: NCT02702596, on 03/20/2016. Retrospectively registered.

scholarly journals A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Christine Elizabeth Jones ◽  
Anna Calvert ◽  
Jo Southern ◽  
Mary Matheson ◽  
Nick Andrews ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Pertussis Toxin ◽  
Geometric Mean ◽  
Control Group ◽  
Primary Immunization ◽  
Link Type ◽  
In Pregnancy ◽  
Pertussis Antigens ◽  
Phase Iv

Abstract Background Pertussis vaccines containing three or five pertussis antigens are recommended in pregnancy in many countries, but no studies have compared the effect on infants’ antigen-specific immunoglobulin G (IgG) concentrations. The aim of this study was to compare anti-pertussis IgG responses following primary immunization in infants of mothers vaccinated with TdaP5-IPV (low dose diphtheria toxoid, tetanus toxoid, acellular pertussis [five antigens] and inactivated polio) or TdaP3-IPV in pregnancy (three pertussis antigens). Methods This multi-centre phase IV randomized clinical trial was conducted in a tertiary referral centre and primary care sites in England. Women were randomized to receive TdaP5-IPV (n = 77) or TdaP3-IPV (n = 77) at 28–32 gestational weeks. A non-randomized control group of 44 women who had not received a pertussis-containing vaccine in pregnancy and their 47 infants were enrolled post-partum. Results Following infant primary immunization, there was no difference in the geometric mean concentrations (GMCs) of anti-pertussis toxin, filamentous haemagglutinin or pertactin IgG between infants born to women vaccinated with TdaP5-IPV (n = 67) or TdaP3-IPV (n = 63). However, the GMC of anti-pertussis toxin IgG was lower in infants born to TdaP5-IPV- and TdaP3-IPV-vaccinated mothers compared to infants born to unvaccinated mothers (n = 45) (geometric mean ratio 0.71 [0.56–0.90] and 0.78 [0.61–0.98], respectively); by 13 months of age, this difference was no longer observed. Conclusion Blunting of anti-pertussis toxin IgG response following primary immunization occurs in infants born to women vaccinated with TdaP5-IPV and TdaP3-IPV, with no difference between maternal vaccines. The blunting effect had resolved by 13 months of age. These results may be helpful for countries considering which pertussis-containing vaccine to recommend for use in pregnancy. Trial registration ClinicalTrials.gov, NCT02145624, registered 23 May 2014

scholarly journals NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Anne van der Meij ◽  
Marianne A. A. van Walderveen ◽  
Nyika D. Kruyt ◽  
Erik W. van Zwet ◽  
Eric J. Liebler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Vagus Nerve ◽  
Randomized Clinical Trial ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Standard Treatment ◽  
Infarct Volume ◽  
Non Invasive ◽  
Link Type

Abstract Background Secondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. In animal models, vagus nerve stimulation (VNS) inhibits these detrimental changes and thereby reduces tissue injury. The aim of this study is to investigate whether non-invasive cervical VNS (nVNS) in addition to the current standard treatment can improve penumbral recovery and limit final infarct volume. Methods NOVIS is a single-center prospective randomized clinical trial with blinded outcome assessment. One hundred fifty patients will be randomly allocated (1:1) within 12 h from clinical stroke onset to nVNS for 5 days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day 5 assessed with MRI. Discussion We hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery. The results of this study will be used to assess the viability and approach to power a larger trial to more definitively assess the clinical efficacy of nVNS after stroke. Trial registration ClinicalTrials.govNCT04050501. Registered on 8 August 2019

scholarly journals Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
María Nieves Muñoz-Alcaraz ◽  
Luis Ángel Pérula-de-Torres ◽  
Jesús Serrano-Merino ◽  
Antonio José Jiménez-Vílchez ◽  
María Victoria Olmo-Carmona ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Group Intervention ◽  
Skin Care ◽  
Stage I ◽  
Current Evidence ◽  
Link Type ◽  
Proprioceptive Neuromuscular Facilitation ◽  
Arm Lymphedema

Abstract Background Breast cancer (BC) is a major public health issue. More than one out of five women treated for breast cancer will develop lymphedema in an upper extremity. Current evidence advocates transdisciplinary oncological rehabilitation. Therefore, research in this area is necessary since limited consensus having been reached with regard to the basic essential components of this rehabilitation. Consensus has, however, been reached on the use of decongestive lymphedema therapy (DLT), but due to a lack of tests, the necessary dosages are unknown and its level is moderately strong. This study attempts to verify both the efficacy of activity-oriented proprioceptive antiedema therapy (TAPA), as compared to conventional treatments such as DLT or Complex Physical Therapy (CPT), as well as its efficiency in terms of cost-effectiveness, for patients affected by breast cancer-related arm lymphedema. Methods Controlled, randomized clinical trial with dual stratification, two parallel arms, longitudinal and single blind. 64 women with breast cancer-related arm lymphedema will take part in the study. The experimental group intervention will be the same for stage I and II, and will consist of neuro-dynamic exercises oriented to the activity, proprioceptive neuromuscular facilitation activities and proprioceptive anti-edema bandaging. The control group intervention, depending on the stage, will consist of preventive measures, skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II). Results Sociodemographic and clinical variables will be collected for the measurement of edema volume and ADL performance. Statistical analysis will be performed on intent to treat. Discussion It has been recommended that patient training be added to DLT, as well as a re-designing of patient lifestyles and the promotion of health-related aspects. In addition, clinical trials should be undertaken to assess neural mobilization techniques and proprioceptive neuromuscular facilitation should be included in the therapy. Cohesive bandaging will also be performed as an early form of pressotherapy. The proposed study combines all of these aspects in order to increased comfort and promote the participation of individuals with lymphedema in everyday situations. Limitations The authors have proposed the assessment of the experimental treatment for stages I and II. One possible limitation is the lack of awareness of whether or not this treatment would be effective for other stages as well as the concern for proper hand cleansing during use of bandages, given the current COVID-19 pandemic situation. Trial registration This trial was registered in ClinicalTrials.gov (NCT03762044). Date of registration: 23 November 2018. Prospectively Registered.

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