Diabetes Mellitus
Conditions
Keywords
Patient's Safety, Diabetes mellitus, Public Health for professionals, Safety, Public health
Brief summary
The safety in the diabetic patient refer so much to the accuracy of the treatment and to the handling of the diabetic in security topics. Therefore, is not only an economic question, but a more global concept that means to receive an accurate sanitary attention in line with the available evidences nowadays. OBJECTIVE: To analyse if a brief intervention educative on the primary care professionals is followed of an improvement in the safety of the diabetic patients. METHODS: Cluster Clinical trial, completely in primary care, on 10 basic health areas (BHA) with a random distribution of the educative intervention to realize on the sanitary professionals (5 intervention/5 control). The intervention is an educative system on adults, brief (6 hours) but with periodic reminders. To improve his skills and attitudes for the diabetics. The group control follows his usual clinical practice on the diabetics. The participation was voluntary. The centres have been matched, being comparable in population and other characteristics, except the specific intervention; ranging between the 6-8% the prevalence observed of type 2 diabetes (T2D) in all the cases. Finally, we selected only between 45 until 75 years old as operative age group of the 45 until the 75 years like operative aim. Inclusion criteria: T2D or T1D with age comprised between 45 and 75 years; recorded in the informatic software for primary care. Exclusion criteria: serious or terminal illness or patients controlled exclusively by specialists.
Interventions
6-hour standardized program for adults ( doctors and nurses )
Sponsors
Study design
Eligibility
Inclusion criteria
* Clinical diagnosis of diabetes * Aged between 45 and 75 years
Exclusion criteria
* No data in informatic system * Severe illness * Controlled only by specialists
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycosylated Haemoglobin A1c at Start | Baseline | — |
| Glycosylated Haemoglobin A1c at 6 Months | 6 months | Glycohemoglobin A1c at 6 months. |
Secondary
| Measure | Time frame |
|---|---|
| BMI ( Body Mass Index ) at Start | Baseline |
| BMI at 6 Months | 6 months |
| Blood Pressure ( Systolic / Diastolic ) | Baseline |
| Systolic and Diastolic Blood Pressure | 6 months |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Behavioural program of education for health professionals of the study | 3,307 |
| Control Group Usual healthcare of diabetics patients | 3,523 |
| Total | 6,830 |
Baseline characteristics
| Characteristic | Intervention | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 320 Participants | 522 Participants | 842 Participants |
| Age, Categorical Between 18 and 65 years | 2987 Participants | 3001 Participants | 5988 Participants |
| Region of Enrollment Spain | 3307 participants | 3523 participants | 6830 participants |
| Sex: Female, Male Female | 1907 Participants | 2000 Participants | 3907 Participants |
| Sex: Female, Male Male | 1400 Participants | 1523 Participants | 2923 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 52 | 1 / 87 |
| serious Total, serious adverse events | 0 / 3,307 | 0 / 3,523 |
Outcome results
Glycosylated Haemoglobin A1c at 6 Months
Glycohemoglobin A1c at 6 months.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Glycosylated Haemoglobin A1c at 6 Months | 6.81 Percentage | Standard Deviation 1.49 |
| Control Group | Glycosylated Haemoglobin A1c at 6 Months | 7.00 Percentage | Standard Deviation 1.64 |
Glycosylated Haemoglobin A1c at Start
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Glycosylated Haemoglobin A1c at Start | 6.64 Percentage | Standard Deviation 1.6 |
| Control Group | Glycosylated Haemoglobin A1c at Start | 6.76 Percentage | Standard Deviation 1.67 |
Blood Pressure ( Systolic / Diastolic )
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Blood Pressure ( Systolic / Diastolic ) | Diastolic | 72.6 mmHg | Standard Deviation 11.9 |
| Intervention | Blood Pressure ( Systolic / Diastolic ) | Systolic | 130.3 mmHg | Standard Deviation 18.5 |
| Control Group | Blood Pressure ( Systolic / Diastolic ) | Systolic | 131.5 mmHg | Standard Deviation 18.6 |
| Control Group | Blood Pressure ( Systolic / Diastolic ) | Diastolic | 73.7 mmHg | Standard Deviation 11.8 |
BMI at 6 Months
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | BMI at 6 Months | 30.0 kg/m2 | Standard Deviation 5.2 |
| Control Group | BMI at 6 Months | 30.1 kg/m2 | Standard Deviation 5.8 |
BMI ( Body Mass Index ) at Start
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | BMI ( Body Mass Index ) at Start | 26.9 kg/m2 | Standard Deviation 9.7 |
| Control Group | BMI ( Body Mass Index ) at Start | 27.1 kg/m2 | Standard Deviation 9.6 |
Systolic and Diastolic Blood Pressure
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Systolic and Diastolic Blood Pressure | Systolic | 130.2 mmHg | Standard Deviation 18.4 |
| Intervention | Systolic and Diastolic Blood Pressure | Diastolic | 72.9 mmHg | Standard Deviation 10.5 |
| Control Group | Systolic and Diastolic Blood Pressure | Systolic | 129.9 mmHg | Standard Deviation 19.5 |
| Control Group | Systolic and Diastolic Blood Pressure | Diastolic | 76.2 mmHg | Standard Deviation 12.8 |