Hypertension Clinical Trial
Official title:
Randomized Clinical Trial to Evaluate the Effectiveness of an Intervention Using Mobile Technology for the Treatment of Depressive Symptoms in People With Diabetes or Hypertension
Background: Depression is a usual comorbid event associated to chronic diseases, such as
hypertension and diabetes, constituting an important public health problem, with negative
consequences for patients' quality of life and self-care, as well as for compliance with
medical treatment. In low and middle income countries depression is often unrecognized and
untreated, and there is a lack of human resources to treat depression and other mental
problems in these health care systems.
Aim: The present study aims to test a 6 week low-intensity psychological intervention
(CONEMO) delivered via an applicative for smartphones for people with depressive symptoms and
co-morbid diabetes and/or hypertension recruited in primary health care units, in São Paulo
(Brazil).
Epidemiologic research has clearly established the significant public health importance of
mental disorders in low- and middle-income countries (LMIC) and their chronic nature. Among
mental disorders, depression has become a major problem as a single condition and, more
often, as part of complex clinical pictures in which multiple conditions and risk factors are
combined.
There is substantial co-morbidity between depression and chronic physical conditions, and
outcome of both conditions is impaired when there is this co-morbidity. Most of the disease
burden in LA is now explained by chronic diseases, including depression, cardio-vascular
diseases -mostly hypertension related- and diabetes. Despite the public health impact of
depression, it often goes unrecognized and untreated. One factor for this treatment gap is
the lack of financial and human resources. The limited mental health resources available in
LMIC are often not optimally distributed either. Funds and trained personnel are typically
allocated in tertiary health care services, such as psychiatric hospitals.
Therefore, any short- and medium-term efforts to develop, evaluate, and disseminate effective
mental health interventions in LMIC must adapt to these severe workforce, resource
limitations, and inequities. The mental health field needs to consider developing self-help
automated interventions that can reach people where there are no health care providers. This
can be partially addressed through two strategies: 1) increasing effective self-management;
and 2) through task-shifting roles to less specialized but appropriately trained health
workers.
We are conducting a community cluster randomized trial with individuals with chronic diseases
(hypertension and/or diabetes) and symptoms of depression, attending primary care clinics in
São Paulo, Brazil. Participating clinics (20) will be randomly allocated to have their nurse
assistants trainned and supervised to monitor an intervention based on behavior activation
(experimental group) delivered by an applicative for smartphones (CONEMO) or to receive
routine care (control group). The focus of this project is on patients helping themselves
through the use of resources that provide continuous advice, support, and motivation.
However, studies suggest that depressed patients left alone with their own devices fail to
make good use of self-help interventions. Nurse assistants will assist participants by a
web-based automated interface connected to the smartphone application (CONEMO) and will
receive supervision in this task once a week.
Method:
CONEMO is a cluster randomized controlled trial conducted with 880 chronic patients who
present diabetes and/ or hypertension and with depression, receiving health care in 20
Primary Care Units with Family Health Program in Sao Paulo, Brazil. Of these, half (10) will
deliver the intervention CONEMO and half (10) will deliver usual care.
The intervention, based in behavior activation, is delivered by a smartphone and monitored by
health professionals (nurse assistants) working at the primary care unit responsible for the
care of the patient. The CONEMO intervention is based on behavior activation and is delivered
by an applicative for smartphones 3 times a week during 6 weeks, with a total of 18 sessions.
A nurse assistant mediates this intervention, motivating the patient and monitoring his/her
performance. Intensity of depressive symptoms and suicidal ideation is assessed by research
assistants using the PHQ-9 and standardized protocols for suicidal risk at baseline, 3- and
6-month follow-ups.
The primary outcome is remission of depressive symptoms 3 months after inclusion in the
study. Secondary outcomes include remission of depressive symptoms at 6 months after
inclusion, social support, quality of life, compliance to medication, suicidal ideation and
activities performed.
The effectiveness and cost-effectiveness of the intervention will be assessed with
intention-to-treat analysis, using the clinical outcome and the assessment of quality of life
(EQ-5D) 3 and 6 months after inclusion in the trial and the use of health services.
Primary Outcome Measures:
Patient Health Questionnaire (PHQ-9) score 3 months after inclusion in the study.
A 50% reduction in the PHQ-9 score from baseline will be considered success.
Secondary Outcome Measures:
Depression - Patient Health Questionnaire (PHQ-9), Quality of life-EQD5, Adherence to
medication-Morisky; Social functioning- WHODAS, Daily activities (BADS).
Time Frame: 6 months after inclusion in the study. A 50% reduction on the PHQ-9 score from
baseline will be considered success.
Cost effectiveness measures (3 and 6 months). Use of health services and medication. General
Quality of life (EQ-5D).
Process evaluation:
Data collected in the interviews with participants and Nurse Assistants about CONEMO system.
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