Hypertension Clinical Trial
— Latin-MHOfficial 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
Verified date | October 2018 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 880 |
Est. completion date | August 31, 2018 |
Est. primary completion date | March 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Attending one of 20 selected primary care clinics - Clinical diagnosis of diabetes and/or hypertension - Presenting with depressive symptoms (PHQ-9 =10) Exclusion Criteria: - Moderate to high suicidal risk (assessed with a standardized protocol) - Not able to read |
Country | Name | City | State |
---|---|---|---|
Brazil | Faculdade de Medicina da Universidade de Sao Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | London School of Hygiene and Tropical Medicine, National Institute of Mental Health (NIMH), Northwestern University, Universidad Peruana Cayetano Heredia |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with 50% reduction in PHQ-9 score a 3-month assessment | Presence and severity of depressive symptoms is measured with the PHQ-9. A 50% reduction in PHQ-9 score at 3-month assessment as compared to PHQ-9 score at baseline will be considered as treatment success. | 3 months after enrollment | |
Secondary | Number of participants with 50% reduction in PHQ-9 score a 6-month assessment | Presence and severity of depressive symptoms is measured with the PHQ-9. A 50% reduction in PHQ-9 score at 6-month assessment as compared to PHQ-9 score at baseline will be considered as treatment success. | 6 months after enrollment | |
Secondary | Improvement in scores for Quality of Life, as measured by the EQD5 | Quality of life is measured with the EQ-5D, a standardized instrument that investigates 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | 3 and 6 months after enrollment | |
Secondary | Proportion of participants who improve adherence to diabetes or hypertension medications, evaluated by the Morisky questionnaire | proportion of patients who improve adherence to diabetes or hypertension medication 3 and 6 months after enrollment, as compared to baseline, using the Morisky Medication Adherence Scale (MMAS-4). The distribution of MMAS-4 scores according to the level of medication adherence is: High adherence (0), Medium adherence (1-2) and Low adherence. | 3 and 6 months after enrollment | |
Secondary | Number of medical consultations, hospitalizations, and visits to the primary care team | Data on the use of health services will be collected at baseline, 3-month and six-month follow-up. At each assessment, information about medical consultations, hospitalizations, and visits to the primary care team will be obtained with a standardized questionnaire. | 3 and 6 months after enrollment | |
Secondary | Proportion of participants who improve level of activity, as evaluated by the short form of the Behavioral Activation for Depression Scale (BADS) | Level of daily activity: assessed at baseline, 3-month, and 6-month follow-up visits using the short form of the Behavioral Activation for Depression Scale BADS. It is a 9-item scale used to measure the frequency of activation and avoidance behaviors hypothetically underlying depression mechanisms. | 3 and 6 months after enrollment |
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