Depression
Conditions
Keywords
Medication adherence, Antidepressive agents, Primary care, Pharmaceutical care
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPharmaceutical care program for antidepressant treatment
The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.
Sponsors
Carlos III Health Institute
Catalan Institute of Health
University of Barcelona
Fundació Sant Joan de Déu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis for depression from a general practitioner * Beginning a pharmacological antidepressant treatment * Going to one of the participant community pharmacies
Exclusion criteria
* Used antidepressant medication in the past 2 months * Had an appointment with an specialist in mental disorders in the past 2 months * History of psychotic or bipolar episodes * History of drug abuse or dependency * Cognitive impairment that not allows assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Antidepressant Medication | At 3 and 6 months | Adherence to antidepressant medication was measured through Pharmacy records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Wellbeing | 0, 3 and 6 months | 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care The control group will be receiving usual medical and pharmaceutical care. | 92 |
| 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. | 87 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 23 |
Baseline characteristics
| Characteristic | Usual Care | Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 27 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 60 Participants | 130 Participants |
| Age, Continuous | 48.4 years STANDARD_DEVIATION 15.9 | 49.4 years STANDARD_DEVIATION 15.1 | 48.9 years STANDARD_DEVIATION 15.5 |
| Region of Enrollment Spain | 92 participants | 87 participants | 179 participants |
| Sex: Female, Male Female | 77 Participants | 58 Participants | 135 Participants |
| Sex: Female, Male Male | 15 Participants | 29 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 92 | 0 / 87 |
| serious Total, serious adverse events | 0 / 92 | 0 / 87 |
Outcome results
Primary
Adherence to Antidepressant Medication
Adherence to antidepressant medication was measured through Pharmacy records
Time frame: At 3 and 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Adherence to Antidepressant Medication | 3 months | 78.4 percentage of adherence patients |
| Intervention Group | Adherence to Antidepressant Medication | 6 months | 60.1 percentage of adherence patients |
| Usual Care | Adherence to Antidepressant Medication | 3 months | 61.9 percentage of adherence patients |
| Usual Care | Adherence to Antidepressant Medication | 6 months | 40.2 percentage of adherence patients |
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.
Time frame: 0, 3 and 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Group | Patient Wellbeing | 6 months | 0.85 units on a scale |
| Intervention Group | Patient Wellbeing | Baseline | 0.58 units on a scale |
| Intervention Group | Patient Wellbeing | 3 months | 0.78 units on a scale |
| Usual Care | Patient Wellbeing | Baseline | 0.66 units on a scale |
| Usual Care | Patient Wellbeing | 3 months | 0.79 units on a scale |
| Usual Care | Patient Wellbeing | 6 months | 0.80 units on a scale |