The value of process evaluation for public health interventions: field-case studies for non-communicable disease prevention and management in five countries.

Complex interventions are needed to effectively tackle non-communicable diseases. However, complex interventions can contain a mix of effective and ineffective actions. Process evaluation (PE) in public health research is of great value as it could clarify the mechanisms and contextual factors associ-ated with variation in the outcomes, better identify effective components, and inform adaptation of the intervention. The aim of this paper is to demonstrate the value of PE through five case studies that span the research cycle. The interven-tions include using digital health, salt reduction strategies, use of fixed dose combinations, and task shifting. Insights of the methods used, and the implications of the PE findings to the project, were discussed. PE of complex interventions can refute or confirm the hypothesized mechanisms of action, thereby enabling intervention refinement, and identifying implementation strategies that can address local contextual needs, so as to improve service delivery and public health outcomes.

Effect of a Digital Intervention on Depressive Symptoms in Patients With Comorbid Hypertension or Diabetes in Brazil and Peru: Two Randomized Clinical Trials.

Importance: Depression is a leading contributor to disease burden globally. Digital mental health interventions can address the treatment gap in low- and middle-income countries, but the effectiveness in these countries is unknown. Objective: To investigate the effectiveness of a digital intervention in reducing depressive symptoms among people with diabetes and/or hypertension. Design, Setting, and Participants: Participants with clinically significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10) who were being treated for hypertension and/or diabetes were enrolled in a cluster randomized clinical trial (RCT) at 20 sites in São Paulo, Brazil (N=880; from September 2016 to September 2017; final follow-up, April 2018), and in an individual-level RCT at 7 sites in Lima, Peru (N=432; from January 2017 to September 2017; final follow-up, March 2018). Interventions: An 18-session, low-intensity, digital intervention was delivered over 6 weeks via a provided smartphone, based on behavioral activation principles, and supported by nurse assistants (n = 440 participants in 10 clusters in São Paulo; n = 217 participants in Lima) vs enhanced usual care (n = 440 participants in 10 clusters in São Paulo; n = 215 participants in Lima). Main Outcomes and Measures: The primary outcome was a reduction of at least 50% from baseline in PHQ-9 scores (range, 0-27; higher score indicates more severe depression) at 3 months. Secondary outcomes included a reduction of at least 50% from baseline PHQ-9 scores at 6 months. Results: Among 880 patients cluster randomized in Brazil (mean age, 56.0 years; 761 [86.5%] women) and 432 patients individually randomized in Peru (mean age, 59.7 years; 352 [81.5%] women), 807 (91.7%) in Brazil and 426 (98.6%) in Peru completed at least 1 follow-up assessment. The proportion of participants in São Paulo with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 40.7% (159/391 participants) in the digital intervention group vs 28.6% (114/399 participants) in the enhanced usual care group (difference, 12.1 percentage points [95% CI, 5.5 to 18.7]; adjusted odds ratio [OR], 1.6 [95% CI, 1.2 to 2.2]; P = .001). In Lima, the proportion of participants with a reduction in PHQ-9 score of at least 50% at 3-month follow-up was 52.7% (108/205 participants) in the digital intervention group vs 34.1% (70/205 participants) in the enhanced usual care group (difference, 18.6 percentage points [95% CI, 9.1 to 28.0]; adjusted OR, 2.1 [95% CI, 1.4 to 3.2]; P < .001). At 6-month follow-up, differences across groups were no longer statistically significant. Conclusions and Relevance: In 2 RCTs of patients with hypertension or diabetes and depressive symptoms in Brazil and Peru, a digital intervention delivered over a 6-week period significantly improved depressive symptoms at 3 months when compared with enhanced usual care. However, the magnitude of the effect was small in the trial from Brazil and the effects were not sustained at 6 months. Trial Registration: ClinicalTrials.gov: NCT02846662 (São Paulo) and NCT03026426 (Lima).

Addressing Depression Comorbid With Diabetes or Hypertension in Resource-Poor Settings: A Qualitative Study About User Perception of a Nurse-Supported Smartphone App in Peru.

BACKGROUND: Smartphone apps could constitute a cost-effective strategy to overcome health care system access barriers to mental health services for people in low- and middle-income countries. OBJECTIVE: The aim of this paper was to explore the patients' perspectives of CONEMO (Emotional Control, in Spanish: Control Emocional), a technology-driven, psychoeducational, and nurse-supported intervention delivered via a smartphone app aimed at reducing depressive symptoms in people with diabetes, hypertension or both who attend public health care centers, as well as the nurses' feedback about their role and its feasibility to be scaled up. METHODS: This study combines data from 2 pilot studies performed in Lima, Peru, between 2015 and 2016, to test the feasibility of CONEMO. Interviews were conducted with 29 patients with diabetes, hypertension or both with comorbid depressive symptoms who used CONEMO and 6 staff nurses who accompanied the intervention. Using a content analysis approach, interview notes from patient interviews were transferred to a digital format, coded, and categorized into 6 main domains: the perceived health benefit, usability, adherence, user satisfaction with the app, nurse's support, and suggestions to improve the intervention. Interviews with nurses were analyzed by the same approach and categorized into 4 domains: general feedback, evaluation of training, evaluation of study activities, and feasibility of implementing this intervention within the existing structures of health system. RESULTS: Patients perceived improvement in their emotional health because of CONEMO, whereas some also reported better physical health. Many encountered some difficulties with using CONEMO, but resolved them with time and practice. However, the interactive elements of the app, such as short message service, android notifications, and pop-up messages were mostly perceived as challenging. Satisfaction with CONEMO was high, as was the self-reported adherence. Overall, patients evaluated the nurse accompaniment positively, but they suggested improvements in the technological training and an increase in the amount of contact. Nurses reported some difficulties in completing their tasks and explained that the CONEMO intervention activities competed with their everyday work routine. CONCLUSIONS: Using a nurse-supported smartphone app to reduce depressive symptoms among people with chronic diseases is possible and mostly perceived beneficial by the patients, but it requires context-specific adaptations regarding the implementation of a task shifting approach within the public health care system. These results provide valuable information about user feedback for those building mobile health interventions for depression.

Use of a Mobile Phone App to Treat Depression Comorbid With Hypertension or Diabetes: A Pilot Study in Brazil and Peru.

BACKGROUND: Depression is underdiagnosed and undertreated in primary health care. When associated with chronic physical disorders, it worsens outcomes. There is a clear gap in the treatment of depression in low- and middle-income countries (LMICs), where specialists and funds are scarce. Interventions supported by mobile health (mHealth) technologies may help to reduce this gap. Mobile phones are widely used in LMICs, offering potentially feasible and affordable alternatives for the management of depression among individuals with chronic disorders. OBJECTIVE: This study aimed to explore the potential effectiveness of an mHealth intervention to help people with depressive symptoms and comorbid hypertension or diabetes and explore the feasibility of conducting large randomized controlled trials (RCTs). METHODS: Emotional Control (CONEMO) is a low-intensity psychoeducational 6-week intervention delivered via mobile phones and assisted by a nurse for reducing depressive symptoms among individuals with diabetes or hypertension. CONEMO was tested in 3 pilot studies, 1 in São Paulo, Brazil, and 2 in Lima, Peru. Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9) at enrollment and at 6-week follow-up. RESULTS: The 3 pilot studies included a total of 66 people. Most participants were females aged between 41 and 60 years. There was a reduction in depressive symptoms as measured by PHQ-9 in all pilot studies. In total, 58% (38/66) of the participants reached treatment success rate (PHQ-9 <10), with 62% (13/21) from São Paulo, 62% (13/21) from the first Lima pilot, and 50% (12/24) from the second Lima pilot study. The intervention, the app, and the support offered by the nurse and nurse assistants were well received by participants in both settings. CONCLUSIONS: The intervention was feasible in both settings. Clinical data suggested that CONEMO may help in decreasing participants' depressive symptoms. The findings also indicated that it was possible to conduct RCTs in these settings.

An exploration into caring for a stroke-survivor in Lima, Peru: Emotional impact, stress factors, coping mechanisms and unmet needs of informal caregivers.

INTRODUCTION: Understanding local complexities and challenges of stroke-related caregiving are essential to develop appropriate interventions. Our study aimed to characterize the impact of post-stroke care among caregivers in a setting of transitioning economy. MATERIALS AND METHODS: Qualitative study based on in-depth interviews with primary caregivers of stroke survivors in Lima, Peru. Transcribed data was organized into the emotional impact of caregiving, main stress factors and coping mechanisms to deal with the caregiving role, as well as the unmet needs of caregivers. RESULTS: We interviewed twelve caregivers, mean age 52.5 years, 8/12 were females, who were either the spouse or child of the stroke survivor. Stroke patients had a median age of 70 years, range 53-85 years. All participants reported having experienced emotional stress and depressive symptoms as a result of caregiving. Although most had family support, reduced social activities and added unanticipated financial burdens increased caregiver's stress. None of the caregivers had received training in post-stroke care tasks after the patient's discharge and only a few had received some psychological support, yet almost all expressed the need to see a professional to improve their mental health. Keeping a positive attitude towards their relative's physical post-stroke condition was a key coping mechanism. CONCLUSIONS: In the absence of structured institutional responses, family members endure with the provision of care for stroke survivors, a task escorted by major emotional, financial, and social strains. This burden could be prevented or curtailed if caregivers were to be targeted by interventions providing psychological and financial support, together with basic training on post-stroke care.

Peruvian Mental Health Reform: A Framework for Scaling-up Mental Health Services.

BACKGROUND: Mental, neurological, and substance (MNS) use disorders are a leading cause of disability worldwide; specifically in Peru, MNS affect 1 in 5 persons. However, the great majority of people suffering from these disorders do not access care, thereby making necessary the improvement of existing conditions including a major rearranging of current health system structures beyond care delivery strategies. This paper reviews and examines recent developments in mental health policies in Peru, presenting an overview of the initiatives currently being introduced and the main implementation challenges they face. METHODS: Key documents issued by Peruvian governmental entities regarding mental health were reviewed to identify and describe the path that led to the beginning of the reform; how the ongoing reform is taking place; and, the plan and scope for scale-up. RESULTS: Since 2004, mental health has gained importance in policies and regulations, resulting in the promotion of a mental health reform within the national healthcare system. These efforts crystallized in 2012 with the passing of Law 29889 which introduced several changes to the delivery of mental healthcare, including a restructuring of mental health service delivery to occur at the primary and secondary care levels and the introduction of supporting services to aid in patient recovery and reintegration into society. In addition, a performance-based budget was approved to guarantee the implementation of these changes. Some of the main challenges faced by this reform are related to the diversity of the implementation settings, eg, isolated rural areas, and the limitations of the existing specialized mental health institutes to substantially grow in parallel to the scaling-up efforts in order to be able to provide training and clinical support to every region of Peru. CONCLUSION: Although the true success of the mental healthcare reform will be determined in the coming years, thus far, Peru has achieved a number of legal, policy and fiscal milestones, thereby presenting a unique and fertile environment for the expansion of mental health services.