Trial Outcomes & Findings for Impact of Pharmaceutical Care in Diabetics Patients (NCT NCT01580904)
NCT ID: NCT01580904
Last Updated: 2017-02-10
Results Overview
average glycated hemoglobin over 24 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2017-02-10
Participant Flow
From September 2009 to December 2011.Medical clinic
The exclusion criteria were (i) to have an infectious disease during the study, (ii) to miss three consecutive appointments, (iii) to stop the use of the hypoglycemic drugs by order of the doctor, and (iv) to deny the acceptance of the term of free and informed consent (TFIC).
Participant milestones
| Measure |
Intervention Group
Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
|
Control Group
Patients will not be followed by the pharmacist.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
49
|
|
Overall Study
COMPLETED
|
47
|
42
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Pharmaceutical Care in Diabetics Patients
Baseline characteristics by cohort
| Measure |
Intervention Group
n=47 Participants
Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
|
Control Group
n=42 Participants
Patients will not be followed by the pharmacist.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Gender
Female
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Gender
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
47 participants
n=5 Participants
|
42 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Data are glycated hemoglobin means of all patients per group.
average glycated hemoglobin over 24 weeks
Outcome measures
| Measure |
Control Group
n=42 Participants
Patients will not be followed by the pharmacist.
|
Intervention Group
n=47 Participants
Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
|
|---|---|---|
|
Glycated Hemoglobin
|
7.2 percent (%)
Standard Deviation 1.5
|
7.1 percent (%)
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Up to 24 weeksaverage fasting glycemia over 24 weeks
Outcome measures
| Measure |
Control Group
n=42 Participants
Patients will not be followed by the pharmacist.
|
Intervention Group
n=47 Participants
Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
|
|---|---|---|
|
Fasting Glycemia
|
157.7 mg/dL
Standard Deviation 43.1
|
159.3 mg/dL
Standard Deviation 56.7
|
SECONDARY outcome
Timeframe: Up to 24 weeksaverage total cholesterol over 24 weeks
Outcome measures
| Measure |
Control Group
n=42 Participants
Patients will not be followed by the pharmacist.
|
Intervention Group
n=47 Participants
Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
|
|---|---|---|
|
Total Cholesterol
|
209.9 mg/dL
Standard Deviation 42.8
|
191.1 mg/dL
Standard Deviation 36.5
|
SECONDARY outcome
Timeframe: Up to 24 weeksaverage LDL cholesterol over 24 weeks
Outcome measures
| Measure |
Control Group
n=42 Participants
Patients will not be followed by the pharmacist.
|
Intervention Group
n=47 Participants
Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
|
|---|---|---|
|
LDL Cholesterol
|
131.0 mg/dL
Standard Deviation 33.0
|
110.8 mg/dL
Standard Deviation 32.4
|
Adverse Events
Control Group
Serious events: 31 serious events
Other events: 30 other events
Deaths: 0 deaths
Intervention Group
Serious events: 34 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=42 participants at risk
Patients will not be followed by the pharmacist.
|
Intervention Group
n=47 participants at risk
Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
|
|---|---|---|
|
Gastrointestinal disorders
Stomach pain
|
73.8%
31/42
|
72.3%
34/47
|
Other adverse events
| Measure |
Control Group
n=42 participants at risk
Patients will not be followed by the pharmacist.
|
Intervention Group
n=47 participants at risk
Patients will be followed by the pharmacist.
Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
|
|---|---|---|
|
Cardiac disorders
Queasiness
|
71.4%
30/42
|
68.1%
32/47
|
Additional Information
Impacto da Atenção Farmacêutica em pacientes diabéticos (IPCD)
Universidade Estadual da Paraíba
Phone: 558387010977
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place