Fidelity of Implementation of Prospera Digital: Evaluation of a Multi-Site mHealth Intervention Aimed at Improving Maternal Health Outcomes in Mexico

ABSTRACT Background Infrastructure and human capital limitations motivate the design of mHealth programs, but their large-scale implementation may be challenging in a development context. Prospera Digital (PD) is a pilot mHealth intervention aiming to improve maternal and child health and nutrition designed as a randomized controlled trial with 3 treatment arms. It was implemented during 2015–2017 in 326 treatment clinics located in 5 states in Mexico. Objective Assess, with an external evaluation, PD's fidelity of implementation using 6 dimensions: adherence, quality, responsiveness, intervention complexity, facilitation strategies, and program differentiation. Methods Benchmark for implementation was first established by interviewing PD's developers. Extensive fieldwork in the 5 states was then conducted to assess its fidelity in heterogeneous contexts. The evaluation team visited 39 health clinics to assess the initial sign-up events and conduct a follow-up. Overall, the team made 28 closed observations; conducted 17 focus groups; and interviewed 74 health providers, 10 community leaders, and 92 beneficiaries. Field notes from the implementation team on all clinics were also examined. Results Co-ordination between the Health and Social Development ministries was adequate, although some health providers were not informed about PD. Program developers added useful implementation strategies during roll-out to reinforce sign-up events. Key quality facilitators were the clarity and relevance of the messages from the short messages service. Beneficiaries expressed high satisfaction with PD. In contrast, implementation barriers to adherence in some localities might reduce the potential impact of PD. Program differentiation was low between the 3 treatment arms. Conclusions PD is a promising strategy to contribute to the promotion of early childhood development in Mexico. Implementation science evaluation can help improve the quality of large-scale mHealth interventions by anticipating barriers and providing insights on how to increase performance. This is especially relevant to inform impact evaluation in development contexts. The trial was registered at the American Economic Association's registry for randomized controlled trials with trial registry number ‘AEARCTR-0001035’.

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A process for establishing and maintaining inter-rater reliability for two observation instruments as a fidelity of implementation measure: A large-scale randomized controlled trial perspective

Studies In Educational Evaluation ◽

10.1016/j.stueduc.2019.04.008 ◽

2019 ◽

Vol 62 ◽

pp. 18-29 ◽

Cited By ~ 4

Author(s):

Fuhui Tong ◽

Shifang Tang ◽

Beverly J. Irby ◽

Rafael Lara-Alecio ◽

Cindy Guerrero ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Large Scale ◽

Controlled Trial ◽

Fidelity Of Implementation ◽

Rater Reliability ◽

Randomized Controlled ◽

Observation Instruments

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Should all Hypertensive Patients be Screened for Primary Aldosteronism?

Current Hypertension Reviews ◽

10.2174/1573402114666180507153549 ◽

2019 ◽

Vol 15 (1) ◽

pp. 54-56

Author(s):

Stelina Alkagiet ◽

Konstantinos Tziomalos

Keyword(s):

Resistant Hypertension ◽

Primary Aldosteronism ◽

Large Scale ◽

Controlled Trial ◽

The Other ◽

Limited Data ◽

Hypertensive Patients ◽

Randomized Controlled ◽

Increased Risk ◽

Prospective Randomized Controlled Trial

Primary aldosteronism (PA) is not only a leading cause of secondary and resistant hypertension, but is also quite frequent in unselected hypertensive patients. Moreover, PA is associated with increased cardiovascular risk, which is disproportionate to BP levels. In addition, timely diagnosis of PA and prompt initiation of treatment attenuate this increased risk. On the other hand, there are limited data regarding the usefulness of screening for PA in all asymptomatic or normokalemic hypertensive patients. More importantly, until now, no well-organized, large-scale, prospective, randomized controlled trial has proved the effectiveness of screening for PA for improving clinical outcome. Accordingly, until more relevant data are available, screening for PA should be considered in hypertensive patients with spontaneous or diuretic-induced hypokalemia as well as in those with resistant hypertension. However, screening for PA in all hypertensive patients cannot be currently recommended.

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Overcoming the Challenges of Experimental Research: Lessons From a Criminal Justice Case Study Involving TASER Exposure

Evaluation Review ◽

10.1177/0193841x18803205 ◽

2018 ◽

Vol 42 (3) ◽

pp. 358-385 ◽

Cited By ~ 1

Author(s):

Natalie Todak ◽

Michael D. White ◽

Lisa M. Dario ◽

Andrea R. Borrego

Keyword(s):

Criminal Justice ◽

Large Scale ◽

Human Subjects ◽

Controlled Trial ◽

Human Subjects Research ◽

Case Study Approach ◽

Study Approach ◽

Randomized Controlled ◽

The Impact

Objective: To provide guidance to criminologists for conducting experiments in light of two common discouraging factors: the belief that they are overly time-consuming and the belief that they can compromise the ethical principles of human subjects’ research. Method: A case study approach is used, based on a large-scale randomized controlled trial experiment in which we exposed participants to a 5-s TASER shock, to describe how the authors overcame ethical, methodological, and logistical difficulties. Results: We derive four pieces of advice from our experiences carrying out this experimental trial: (1) know your limitations, (2) employ pilot testing, (3) remain flexible and patient, and (4) “hold the line” to maintain the integrity of the research and the safety of human subjects. Conclusions: Criminologists have an obligation to provide the best possible evidence regarding the impact and consequences of criminal justice practices and programs. Experiments, considered by many to be the gold standard of empirical research methodologies, should be used whenever possible in order to fulfill this obligation.

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Voice-Message–Based mHealth Intervention to Reduce Postoperative Penetrative Sex in Recipients of Voluntary Medical Male Circumcision in the Western Cape, South Africa: Protocol of a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/resprot.5958 ◽

2016 ◽

Vol 5 (3) ◽

pp. e155 ◽

Cited By ~ 2

Author(s):

Sarah C Thomsen ◽

Donald Skinner ◽

Yoesrie Toefy ◽

Tonya Esterhuizen ◽

Michael McCaul ◽

...

Keyword(s):

South Africa ◽

Randomized Controlled Trial ◽

Male Circumcision ◽

Controlled Trial ◽

Voluntary Medical Male Circumcision ◽

Western Cape ◽

Medical Male Circumcision ◽

Mhealth Intervention ◽

Randomized Controlled ◽

Voice Message

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Delivery of Peer Support Through a Self-Management mHealth Intervention (Healing Circles) in Patients With Cardiovascular Disease: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.12322 ◽

2018 ◽

Author(s):

Brodie M Sakakibara ◽

Santabhanu Chakrabarti ◽

Andrew Krahn ◽

Martha H Mackay ◽

Tara Sedlak ◽

...

Keyword(s):

Cardiovascular Disease ◽

Randomized Controlled Trial ◽

Usual Care ◽

Peer Support ◽

Controlled Trial ◽

Health Care Use ◽

Self Management ◽

Mhealth Intervention ◽

Randomized Controlled ◽

Questionnaire Version

BACKGROUND Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed. OBJECTIVE In this paper, we report on a protocol to evaluate Healing Circles—an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care. METHODS In this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months. RESULTS The study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019. CONCLUSIONS Healing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use. CLINICALTRIAL ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12322

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The translation of an evidence-based preschool physical activity intervention from in-person to online delivery of professional development to preschool teachers

Translational Behavioral Medicine ◽

10.1093/tbm/ibz076 ◽

2019 ◽

Vol 9 (6) ◽

pp. 1186-1196 ◽

Cited By ~ 1

Author(s):

Ruth P Saunders ◽

Michaela A Schenkelberg ◽

Christina Moyer ◽

Erin K Howie ◽

William H Brown ◽

...

Keyword(s):

Professional Development ◽

Large Scale ◽

Physical Activity Intervention ◽

Preschool Teachers ◽

Controlled Trial ◽

Development Program ◽

Evidence Based ◽

Timely Manner ◽

Online Delivery ◽

Randomized Controlled

An intervention shown to be effective in a randomized controlled trial can be translated into an online professional development program and disseminated on a large scale in a timely manner.

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Sauna Yoga Superiorly Improves Flexibility, Strength, and Balance: A Two-Armed Randomized Controlled Trial in Healthy Older Adults

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16193721 ◽

2019 ◽

Vol 16 (19) ◽

pp. 3721 ◽

Cited By ~ 2

Author(s):

Bucht ◽

Donath

Keyword(s):

Large Scale ◽

Controlled Trial ◽

Pilot Trial ◽

Intervention Group ◽

Control Group ◽

Minimization Method ◽

Important Indicator ◽

Randomized Controlled ◽

Eyes Closed ◽

Healthy Elderly

Besides strength and balance, flexibility is an important indicator of health-related physical fitness. Thus, the aim of this two-armed randomized controlled pilot trial was to investigate whether sauna yoga at a moderate temperature (50 °C) beneficially affects flexibility, strength, balance, and quality of life (QOL) in healthy elderly community dwellers. Participants were randomly assigned to an intervention group (INT, n = 11, age: 68.7 ± 5.9) or control group (CON, n = 12, age: 69.3 ± 4.9), using the minimization method. Age, physical activity, gender, and the primary outcome flexibility were used as strata for group allocation. Both groups completed similar exercises in the sauna over eight weeks. Only the INT group was exposed to moderate temperatures of 50 °C. Large and statistically significant improvement in favor of the sauna group (INT) was observed for the chair sit-and-reach test (INT: +83%, CON +3%, p = 0.028, nр² = 0.24). The shoulder and lateral spine flexibility were not relevantly affected. Strength in the lower extremities merely showed a tendency to significant changes (INT: 16%, CON: 3%, p = 0.061, nр² = 0.181). Additionally, balance abilities, with eyes closed, improved (INT: 187%, CON +58%, p = 0.056, nр² = 0.189) in favor of the INT group. QOL only improved in favor of the INT for environmental dimension (INT: +7%, CON: 0%, p = 0.034, nр² = 0.227). These first but preliminary findings indicate that sauna yoga may serve as a promising and feasible means to improve flexibility in elderly people. Strength and balance do not meaningfully benefit from a sauna environment, although strength improved to a slightly higher extent in the sauna group. Future large-scale research is needed to elucidate underlying mechanisms and corroborate these findings

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Unfractionated heparin in acute chest syndrome: a pilot feasibility randomized controlled trial of unfractionated heparin vs. standard of care in acute chest syndrome

Pilot and Feasibility Studies ◽

10.1186/s40814-020-00715-w ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Craig D. Seaman ◽

Enrico Novelli ◽

Laura De Castro ◽

Margaret V. Ragni

Keyword(s):

Unfractionated Heparin ◽

Large Scale ◽

Controlled Trial ◽

Standard Of Care ◽

Phase Iii ◽

Therapeutic Modality ◽

Red Blood Cell Transfusion ◽

Acute Chest Syndrome ◽

Open Label ◽

Randomized Controlled

Abstract Background Acute chest syndrome (ACS) is the leading cause of mortality in sickle cell disease (SCD). The pathogenesis of ACS is complex and not entirely understood with multiple etiologies likely contributing simultaneously. One particular etiology is pulmonary vascular occlusion due to thrombosis. Thus, anticoagulation is an attractive therapeutic modality. Methods This was a single-center, randomized controlled, open-label, pilot study to determine the feasibility of performing a larger multicenter phase III trial to assess the effects of unfractionated heparin (UFH) in ACS. Subjects were randomized within 24 h of diagnosis of ACS to one of two treatment arms, UFH, and standard of care (SOC), or no UFH and SOC. UFH was given intravenously for 7 days, or until discharge, if discharge was shorter than 7 days. SOC consisted of intravenous fluids, antibiotics, supplemental oxygen, analgesia, red blood cell transfusion, and exchange transfusion. Results From July 2014 to June 2018, a total of 7 patients underwent randomization (four patients received UFH in addition to SOC and 3 patients received SOC only). Two of the prespecified feasibility criteria were not met: the capacity to consent eligible individuals and the timely notification of hospitalized patients with ACS necessary to permit randomization within 24 h of diagnosis; thus, as a result of poor enrollment, the study was terminated early. The duration of hospitalization was 279.43 (SD 267.98) and 127.31 (SD 137.70) h in the UFH and SOC arms, respectively. The duration of hypoxemia, leukocytosis, fever, and moderate to severe pain was 117.52 (SD 60.52), 24.90 (SD 29.69), 117.52 (SD 60.52), and 117.52 (SD 60.52) h, respectively, in the UFH group, and 51.49 (SD 44.79), 0, 53.11 (SD 25.06), and 88.68 (SD 72.77) h, respectively, in the SOC group. No major bleeding was noted in either group. Conclusions Our study did not achieve prespecified feasibility criteria, resulting in poor enrollment and early termination, and serves to highlight some of the pitfalls experienced in clinical research in SCD. It did show the use of UFH without any major adverse events in 7 subjects. No future large-scale study is planned. Trials registration Registered at ClinicalTrials.gov (NCT #02098993) on March 28, 2014.

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