scholarly journals Protocol of a parallel group Randomized Control Trial (RCT) for Mobile-assisted Medication Adherence Support (Ma-MAS) intervention among Tuberculosis patients

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261758
Author(s):  
Zekariyas Sahile ◽  
Lua Perimal-Lewis ◽  
Paul Arbon ◽  
Anthony John Maeder
Keyword(s):  
Medication Adherence ◽  
Randomized Control Trial ◽  
Standard Treatment ◽  
Healthcare Providers ◽  
Intervention Group ◽  
Self Report ◽  
Phone Calls ◽  
Parallel Group ◽  
Adherence Support ◽  
Randomized Control

Background Non-adherence to Tuberculosis (TB) medication is a serious threat to TB prevention and control programs, especially in resource-limited settings. The growth of the popularity of mobile phones provides opportunities to address non-adherence, by facilitating direct communication more frequently between healthcare providers and patients through SMS texts and voice phone calls. However, the existing evidence is inconsistent about the effect of SMS interventions on TB treatment adherence. Such interventions are also seldom developed based on appropriate theoretical foundations. Therefore, there is a reason to approach this problem more rigorously, by developing the intervention systematically with evidence-based theory and conducting the trial with strong measurement methods. Methods This study is a single-blind parallel-group design individual randomized control trial. A total of 186 participants (93 per group) will be individually randomized into one of the two groups with a 1:1 allocation ratio by a computer-generated algorithm. Group one (intervention) participants will receive daily SMS texts and weekly phone calls concerning their daily medication intake and medication refill clinic visit reminder and group two (control) participants will receive the same routine standard treatment care as the intervention group, but no SMS text and phone calls. All participants will be followed for two months of home-based self-administered medication during the continuation phases of the standard treatment period. Urine test for the presence of isoniazid (INH) drug metabolites in urine will be undertaken at the random point at the fourth and eighth weeks of intervention to measure medication adherence. Medication adherence will also be assessed by self-report measurements using the AIDS Clinical Trial Group adherence (ACTG) and Visual Analogue Scales (VAS) questionnaires, and clinic appointment attendance registration. Multivariable regression model analysis will be employed to assess the effect of the Ma-MAS intervention at a significance level of P-value < 0.05 with a 95% confidence interval. Discussion For this trial, a mobile-assisted medication adherence intervention will first be developed systematically based on the Medical Research Council framework using appropriate behavioural theory and evidence. The trial will then evaluate the effect of SMS texts and phone calls on TB medication adherence. Evidence generated from this trial will be highly valuable for policymakers, program managers, and healthcare providers working in Ethiopia and beyond. Trial registration The trial is registered in the Pan-Africa Clinical Trials Registry with trial number PACTR202002831201865.

scholarly journals The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Andrew Medina-Marino ◽  
Dana Bezuidenhout ◽  
Sybil Hosek ◽  
Ruanne V. Barnabas ◽  
Millicent Atujuna ◽  
...  
Keyword(s):  
South Africa ◽  
Adolescent Girls ◽  
Young Women ◽  
Randomized Control Trial ◽  
Community Based ◽  
Adherence Support ◽  
Randomized Control ◽  
Exposure Prophylaxis ◽  
Effective Use ◽  
Improve Access

Abstract Background HIV incidence among South African adolescent girls and young women (AGYW) remains high, but could be reduced by highly effective pre-exposure prophylaxis (PrEP). Unfortunately, AGYW report significant barriers to clinic-based sexual and reproductive health services. Even when AGYW access PrEP as an HIV prevention method, poor prevention-effective use was a serious barrier to achieving its optimal HIV prevention benefits. Determining the acceptability and feasibility of community-based platforms to increase AGYW’s access to PrEP, and evaluating behavioural interventions to improve prevention-effective use of PrEP are needed. Methods We propose a mixed-methods study among AGYW aged 16–25 years in Eastern Cape Province, South Africa. In the first component, a cross-sectional study will assess the acceptability and feasibility of leveraging community-based HIV counselling and testing (CBCT) platforms to refer HIV-negative, at-risk AGYW to non-clinic-based, same-day PrEP initiation services. In the second component, we will enrol 480 AGYW initiating PrEP via our CBCT platforms into a three-armed (1:1:1) randomized control trial (RCT) that will evaluate the effectiveness of adherence support interventions to improve the prevention-effective use of PrEP. Adherence will be measured over 24 months via tenofovir-diphosphate blood concentration levels. Qualitative investigations will explore participant, staff, and community experiences associated with community-based PrEP services, adherence support activities, study implementation, and community awareness. Costs and scalability of service platforms and interventions will be evaluated. Discussion This will be the first study to assess the acceptability and feasibility of leveraging CBCT platforms to identify and refer at-risk AGYW to community-based, same-day PrEP initiation services. It will also provide quantitative and qualitative results to inform adherence support activities and services that promote the prevention-effective use of PrEP among AGYW. By applying principles of implementation science, behavioural science, and health economics research, we aim to inform strategies to improve access to and prevention-effective use of PrEP by AGYW. Trial registration ClinicalTrials.govNCT03977181. Registered on 6 June 2019—retrospectively registered.

scholarly journals The Effect of the E-Patuh Application on HIV/Aids Patients’ Adherence in Consuming Antiretroviral

2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Alfian Alfian ◽  
Kusman Ibrahim ◽  
Imas Rafiyah
Keyword(s):  
Health Care ◽  
Medication Adherence ◽  
Health Care Providers ◽  
Antiretroviral Treatment ◽  
Intervention Group ◽  
Self Report ◽  
Care Providers ◽  
Aids Patients ◽  
Antiretroviral Adherence ◽  
Hiv Aids

Medication adherence is behavior that refers to client obeys in following a medication, and makes lifestyle changes in accordance of recommendations from health care providers. Antiretroviral adherence is paramount for HIV/AIDS patients. The effects were often a problem in antiretroviral treatment and toxicity and often be the reason for replacing or stopping antiretroviral treatment. This study aimed to determine the “E-Patuh” Applications effect on antiretroviral adherence in patients Of HIV/AIDS In West Java. The research design was a quasi-experimental with nonequivalent control group design. The location of this research was in RSUD Kota Bandung and in RSUD Kota Banjar. The respondents was selected without randomization and used purposive sampling technique. Respondents in this study were 30 respondents. Data were obtained using self-report questionnaires. The intervention group was monitored a 30-day android-based E-Patuh application and monitored on an E-Patuh website and then measured adherence value with self-report. Data were analyzed using SPSS 22 with chi-square test. The results showed a significant difference between adherence value before and after application of E-Patuh in the intervention group with (p <0.05) with obtained p value = 0,006. The results of this study prove a positive effect on the using of E-Patuh applications against ARV medication adherence in the intervention group with the support system of the E-Patuh application. The used of E-Patuh is helpful in improving ARV adherence in HIV/AIDS patients. The features contained in E-Patuh were directly reminiscent of the timing of taking medication for PWLH. E-Patuh should be consideration for PLHIV and health care providers in hospitals to improve ARV adherence to reduce mortality rates in people living with HIV.

scholarly journals A Systems-Level Approach to Improving Medication Adherence in Hypertensive Latinos: a Randomized Control Trial

2019 ◽  
Vol 35 (1) ◽  
pp. 182-189 ◽  
Author(s):  
Antoinette Schoenthaler ◽  
Franzenith de la Calle ◽  
Maria Pitaro ◽  
Audrey Lum ◽  
William Chaplin ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Randomized Control Trial ◽  
Randomized Control

Pilot Trial of a Social Cognitive Theory-Based Physical Activity Intervention Delivered by Nonsupervised Technology in Persons With Multiple Sclerosis

2015 ◽  
Vol 12 (7) ◽  
pp. 924-930 ◽  
Author(s):  
Yoojin Suh ◽  
Robert W. Motl ◽  
Connor Olsen ◽  
Ina Joshi
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Social Cognitive Theory ◽  
Behavioral Intervention ◽  
Social Cognitive ◽  
Cognitive Theory ◽  
Pilot Trial ◽  
Intervention Group ◽  
Self Report ◽  
Phone Calls

Background:Physical inactivity is prevalent in people with multiple sclerosis (MS) and this highlights the importance of developing behavioral interventions for increasing physical activity (PA) in MS. This pilot trial examined the efficacy of a 6-week, behavioral intervention based on social cognitive theory (SCT) delivered by newsletters and phone calls for increasing PA in persons with MS who were physically inactive and had middle levels of self-efficacy.Methods:The sample included 68 persons with relapsing-remitting MS who were randomly assigned into intervention and control groups. The intervention group received SCT-based information by newsletters and phone calls, whereas the controls received information regarding topics such as stress management over 6 weeks. Participants completed self-report of PA and social cognitive variables.Results:The intervention group had a significant increase in self-reported PA (d = 0.56, P = .02) over the 6 weeks, but the controls had a nonsignificant change (d = –0.13, P = .45). Goal setting was changed in the intervention group (d = 0.68, P ≤ .01) and identified as a significant mediator of change in self-reported PA.Conclusions:This study provides initial evidence for the benefit of a theory-based behavioral intervention for increasing PA in MS.

scholarly journals Effect of lactation counselling on breast feeding: randomized control trial

2017 ◽  
Vol 4 (5) ◽  
pp. 1610
Author(s):  
Ramesh Choudhary ◽  
Chetan Meena ◽  
Sunil Gothwal ◽  
S. Sitaraman ◽  
Sheela Sharma ◽  
...  
Keyword(s):  
Breast Feeding ◽  
Randomized Control Trial ◽  
Tertiary Care ◽  
Intervention Group ◽  
Standard Of Care ◽  
Care Hospital ◽  
Feeding Rates ◽  
Counseling Intervention ◽  
Northern India ◽  
Randomized Control

Background: Breastfeeding for a newborn is a standard of care. Breast feeding rates are documented low in our country. Objective of present study was to find out the effect of lactation counselling on breast feeding rates.Methods: It was an open lable randomized control trial and conducted at Department of Pediatrics and Obstetrics of a tertiary care hospital of Northern India. Eligible subjects were 3rd trimester mothers admitted for delivery. Student t test and chi square test were used.Results: Breast feeding counseling (intervention) group resulted in early imitation, higher breast-feeding rates at discharge and follow up.Conclusions: Breast feeding counselling improves initiation, breast feeding rates at discharge and beyond. This study also emphasizes that lactation counselling is useful. Every opportunity of counselling should be availed by health care workers to promote breast feeding.

A personalized medication management platform (PMMP) to improve medication adherence: A randomized control trial

2017 ◽  
Vol 140 ◽  
pp. 275-281 ◽  
Author(s):  
Chu-Ya Huang ◽  
Phung-Anh Alex Nguyen ◽  
Daniel L. Clinciu ◽  
Chun-Kung Hsu ◽  
Jui-Chia Richard Lu ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Randomized Control Trial ◽  
Medication Management ◽  
Improve Medication Adherence ◽  
Management Platform ◽  
Randomized Control

Efficacy of a home-visiting intervention aimed at improving maternal sensitivity, child attachment, and behavioral outcomes for maltreated children: A randomized control trial

2011 ◽  
Vol 23 (1) ◽  
pp. 195-210 ◽  
Author(s):  
Ellen Moss ◽  
Karine Dubois-Comtois ◽  
Chantal Cyr ◽  
George M. Tarabulsy ◽  
Diane St-Laurent ◽  
...  
Keyword(s):  
Randomized Control Trial ◽  
Home Visiting ◽  
Intervention Group ◽  
Maternal Sensitivity ◽  
Control Group ◽  
Older Children ◽  
Short Term ◽  
Parental Sensitivity ◽  
Child Attachment ◽  
Randomized Control

AbstractThe efficacy of a short-term attachment-based intervention for changing risk outcomes for children of maltreating families was examined using a randomized control trial. Sixty-seven primary caregivers reported for maltreatment and their children (1–5 years) were randomly assigned to an intervention or control group. The intervention group received 8 weekly home visits directed at the caregiver–child dyad and focused on improving caregiver sensitivity. Intervention sessions included brief discussions of attachment–emotion regulation-related themes and video feedback of parent–child interaction. Comparison of pre- and posttest scores revealed significant improvements for the intervention group in parental sensitivity and child attachment security, and a reduction in child disorganization. Older children in the intervention group also showed lower levels of internalizing and externalizing problems following intervention. This is the first study to demonstrate the efficacy of short-term attachment-based intervention in enhancing parental sensitivity, improving child security, and reducing disorganization for children in the early childhood period.

scholarly journals Digital Medication Adherence Support: Could Healthcare Providers Recommend Mobile Health Apps?

2021 ◽  
Vol 2 ◽  
Author(s):  
Claudine Backes ◽  
Carla Moyano ◽  
Camille Rimaud ◽  
Christine Bienvenu ◽  
Marie P. Schneider
Keyword(s):  
Medication Adherence ◽  
Mobile Phones ◽  
Mobile Health ◽  
Data Protection ◽  
Evaluation Method ◽  
Healthcare Providers ◽  
European Economic Area ◽  
Online Questionnaire ◽  
Search Terms ◽  
Adherence Support

Adherence to prescribed medication is suboptimal in 50% of the chronic population, resulting in negative medical and economic outcomes. With the widespread use of mobile phones worldwide, medication adherence apps for mobile phones become promising medication adherence aids thanks to simplicity, user-friendliness, and accessibility for the public. Yet, until today, there is insufficient evidence in favor of using mobile health (mHealth) apps to increase medication adherence. This study aims to develop a methodology for scientific and end-user (patient) mHealth evaluation (a) to identify medication adherence apps search terms, (b) to evaluate identified apps based on scientific criteria, and (c) to report best smartphone apps evaluated by patients. Search terms were identified via literature review and expertise. Firstly, an online questionnaire was developed to identify frequently used search terms by recruited patients. Related medication adherence apps were identified and selected using predefined inclusion criteria. Secondly, identified apps were evaluated thanks to a scientific evaluation method and a created online questionnaire for patient feedback. Recruited patients were invited to test and evaluate the selected apps. Out of 1,833 free-of-charge and 307 paid apps identified, only four free-of-charge and three paid apps remained included in the study after eligibility criteria. None of the selected app reached a high score. Looking at the overall scores, Medisafe (59%), MyTherapy (56%), and Meds on time (44%) received the highest scores in the scientific app evaluation. In the patient evaluation, Dosecast (3.83 out of five points), Medisafe (3.62), and SwissMeds (3.50) received the highest scores. None of the apps in this research has undergone a process for certification, for example, CE marking, through a notified body. Security and data protection aspects of existing apps highly contribute to these low evaluation scores through little information on patient's data processing and storage. This might be corrected through the introduction of General Data Protection Regulation (GDPR) in the European Economic Area (EEA) and more scrutiny through regulatory bodies in the EU/EEA and the USA. None of the applications should be recommended by healthcare providers. In addition, clinical studies with chronic patients are necessary to measure long-term app impacts.

scholarly journals Self-compassion to decrease performance anxiety in climbers: A randomized control trial

2021 ◽  
Vol 6 ◽  
pp. 004
Author(s):  
Philipp Röthlin ◽  
Romaine Leiggener
Keyword(s):  
Randomized Control Trial ◽  
Performance Anxiety ◽  
Intervention Group ◽  
Physical Symptoms ◽  
The Self ◽  
Waiting List ◽  
Control Group ◽  
Self Compassion ◽  
Randomized Control ◽  
Post Assessment

In climbing, anxiety may impair performance. Using an evolutionary approach, we hypothesized that athletes who treat themselves with self-compassion activate their contentment and soothing system and thus reduce their performance anxiety. A two-week randomized control trial was used to investigate the effect of self-compassion on somatic and cognitive anxiety. We compared two groups (intervention and waiting list) on two dates. Sixty climbers (Mage = 27.95, SDage = 8.57) completed the pre- and post-assessment. The intervention consisted of a psychoeducational leaflet and five self-compassionate writing tasks. In the posttest, the self-compassion intervention group showed increased self-compassion (F = 4.33, p = .04, ηp2 = 0.07) and decreased somatic performance anxiety (F = 6.24, p = .02, ηp2 = 0.10) compared to the waiting list control group. We found no changes in cognitive performance anxiety. The results suggest that self-compassion could be considered as a possible intervention to reduce physical symptoms of performance anxiety.

scholarly journals Self-Report Versus Medical Record for Mammography Screening Among Minority Women

2016 ◽  
Vol 38 (12) ◽  
pp. 1627-1638 ◽  
Author(s):  
Karabi Nandy ◽  
Usha Menon ◽  
Laura A. Szalacha ◽  
HanJong Park ◽  
Jongwon Lee ◽  
...  
Keyword(s):  
Medical Records ◽  
Mammography Screening ◽  
Randomized Control Trial ◽  
Minority Women ◽  
Self Report ◽  
Minority Populations ◽  
Community Based ◽  
Randomized Control ◽  
Verification Process ◽  
Reported Data

Self-report is the most common means of obtaining mammography screening data. The purpose of this study was to assess the accuracy of minority women’s self-reported mammography by comparing their self-reported dates of mammograms with those in their medical records from a community-based randomized control trial. We found that out of 192 women, 116 signed the Health Information Portability and Accountability Act form and, among these, 97 had medical records that could be verified (97 / 116 = 83.6%). Ninety-two records matched where both sources confirmed a mammogram; 48 of 92 (52.2%) matched perfectly on self-reported date of mammogram. Complexities in the verification process warrant caution when verifying self-reported mammography screening in minority populations. In spite of some limitations, our findings support the usage of self-reported data on mammography as a validated tool for other researchers investigating mammography screening among minority women who continue to have low screening rates.

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