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| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
| Catalan Institute of Health | OTHER_GOV |
| University of Barcelona | OTHER |
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The purpose of this study is to evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of the study is that pharmacist intervention can improve compliance to antidepressants and patient wellbeing.
The aim of this study is to evaluate the efficacy of a support program in community pharmacy on the improvement of the compliance to antidepressants and the clinic of typical primary care patients under normal practice circumstances. That implies that the intervention is made by pharmacists without any specific requirement that work in the community pharmacies set up in the area of study and on patients following the usual medical circuit. As well, the cost of the support program is calculated in order to set the effectiveness of the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | The control group will be receiving usual medical and pharmaceutical care. | |
| Intervention Group | Experimental | Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmaceutical care program for antidepressant treatment | Behavioral | The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Antidepressant Medication | Adherence to antidepressant medication was measured through Pharmacy records | At 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Wellbeing | Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life. The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health. | 0, 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoni Serrano, MD PhD | Foundation Sant Joan de Deu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Center Doctor Bartomeu Fabres Anglada | Gavà | Barcelona | 08850 | Spain | ||
| Primary Care Center Gavà 1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23950967 | Derived | Rubio-Valera M, Bosmans J, Fernandez A, Penarrubia-Maria M, March M, Trave P, Bellon JA, Serrano-Blanco A. Cost-effectiveness of a community pharmacist intervention in patients with depression: a randomized controlled trial (PRODEFAR Study). PLoS One. 2013 Aug 12;8(8):e70588. doi: 10.1371/journal.pone.0070588. eCollection 2013. | |
| 19656386 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria). |
| FG001 | Intervention Group | Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program. Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | The control group will be receiving usual medical and pharmaceutical care. |
| BG001 | Intervention Group | Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program. Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to Antidepressant Medication | Adherence to antidepressant medication was measured through Pharmacy records | Posted | Number | 95% Confidence Interval | percentage of adherence patients | At 3 and 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Antoni Serrano Blanco | Parc Sanitari Sant Joan de Déu | +34936406350 | 12215 | aserrano@pssjd.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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|
| Gavà |
| Barcelona |
| 08850 |
| Spain |
| Rubio-Valera M, Serrano-Blanco A, Trave P, Penarrubia-Maria MT, Ruiz M, Pujol MM. Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol. BMC Public Health. 2009 Aug 5;9:284. doi: 10.1186/1471-2458-9-284. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patient Wellbeing | Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life. The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health. | Posted | Mean | 95% Confidence Interval | units on a scale | 0, 3 and 6 months |
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | Intervention Group | Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program. Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment. | 0 | 87 | 0 | 87 |
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| D000074822 |
| Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| 6 months |
|