Trial Outcomes & Findings for Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care (NCT NCT00794196)
NCT ID: NCT00794196
Last Updated: 2016-11-22
Results Overview
Adherence to antidepressant medication was measured through Pharmacy records
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
179 participants
Primary outcome timeframe
At 3 and 6 months
Results posted on
2016-11-22
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
87
|
|
Overall Study
COMPLETED
|
87
|
64
|
|
Overall Study
NOT COMPLETED
|
5
|
23
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
23
|
Baseline Characteristics
Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care
Baseline characteristics by cohort
| Measure |
Usual Care
n=92 Participants
The control group will be receiving usual medical and pharmaceutical care.
|
Intervention Group
n=87 Participants
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.
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 15.9 • n=99 Participants
|
49.4 years
STANDARD_DEVIATION 15.1 • n=107 Participants
|
48.9 years
STANDARD_DEVIATION 15.5 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
92 participants
n=99 Participants
|
87 participants
n=107 Participants
|
179 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At 3 and 6 monthsAdherence to antidepressant medication was measured through Pharmacy records
Outcome measures
| Measure |
Intervention Group
n=87 Participants
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.
|
Usual Care
n=92 Participants
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).
|
|---|---|---|
|
Adherence to Antidepressant Medication
3 months
|
78.4 percentage of adherence patients
Interval 48.0 to 93.5
|
61.9 percentage of adherence patients
Interval 26.4 to 88.1
|
|
Adherence to Antidepressant Medication
6 months
|
60.1 percentage of adherence patients
Interval 28.4 to 85.11
|
40.2 percentage of adherence patients
Interval 12.9 to 75.3
|
SECONDARY outcome
Timeframe: 0, 3 and 6 monthsPatient 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.
Outcome measures
| Measure |
Intervention Group
n=87 Participants
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.
|
Usual Care
n=92 Participants
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).
|
|---|---|---|
|
Patient Wellbeing
Baseline
|
0.58 units on a scale
Interval 0.5 to 0.65
|
0.66 units on a scale
Interval 0.58 to 0.75
|
|
Patient Wellbeing
3 months
|
0.78 units on a scale
Interval 0.7 to 0.86
|
0.79 units on a scale
Interval 0.71 to 0.88
|
|
Patient Wellbeing
6 months
|
0.85 units on a scale
Interval 0.76 to 0.93
|
0.80 units on a scale
Interval 0.74 to 0.91
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Antoni Serrano Blanco
Parc Sanitari Sant Joan de Déu
Phone: +34936406350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place