Nurse-led Reminder Program for Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients
Primary Purpose
Diabetes Mellitus, Non-Insulin-Dependent
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nurse-led reminder program through email
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Non-Insulin-Dependent
Eligibility Criteria
Inclusion Criteria:
To be elegible, all subjects had to be diabetics (Diabetes Mellitus, Non-Insulin-Dependent)
- Speaking and reading italian
- Having an active phone number and an email address
- Providing a signed a informed consent
Exclusion Criteria:
- Mental illness
- Hospitalized patients and who refused to partecipate
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nurse-led email program through email
Management of diabetic patients
Arm Description
In addition to usual care and educational program, the intervention group will also receive email alerts and phone calls from the nurse care manager (NCM).
Usual care, educational program and usual management of Diabetic patients
Outcomes
Primary Outcome Measures
Medication adherence
The main outcome of the study was the improvement of medication adherence in diabetic patients between baseline and the end of follow-up.
Secondary Outcome Measures
Trust in nurses
Mean differences between groups in the average scores of trust in nurses perceived by patients between baseline and the end of follow-up.
Lifestyle
Mean differences between groups in the average reduction in smoking and alcohol consumption, BMI and in the average increase of consumption of a healthy diet in diabetic patients between baseline and the end of follow-up.
Contacts with health services
Mean differences between groups in the reduction of the number of contact sand admissions of diabetic patients at health care services, between baseline and the end of follow-up.
Full Information
NCT ID
NCT02196272
First Posted
July 15, 2014
Last Updated
July 18, 2014
Sponsor
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
1. Study Identification
Unique Protocol Identification Number
NCT02196272
Brief Title
Nurse-led Reminder Program for Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients
Official Title
The Efficacy of a Nurse-led Reminder Program on Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
4. Oversight
5. Study Description
Brief Summary
A number of strategies have been evaluated to improve clinical outcomes in diabetics patients, however no studies explored the efficacy of a nurse-led reminder program through email (NRP-e) to improve medication adherence, even if it is fundamental in the management of diabetics. The study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (NRP-e) to improve medication adherence in diabetic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nurse-led email program through email
Arm Type
Experimental
Arm Description
In addition to usual care and educational program, the intervention group will also receive email alerts and phone calls from the nurse care manager (NCM).
Arm Title
Management of diabetic patients
Arm Type
No Intervention
Arm Description
Usual care, educational program and usual management of Diabetic patients
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led reminder program through email
Intervention Description
Both groups will receive an educational program and usual care. The educational program will consist of:
- 1-hour session, during which the NCM give advices and enphasize the importance of the correct procedure of glycemic control, report non-pharmacological strategies for a healty lifestyle and instruction on how to fill a self assessment form.
Primary Outcome Measure Information:
Title
Medication adherence
Description
The main outcome of the study was the improvement of medication adherence in diabetic patients between baseline and the end of follow-up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Trust in nurses
Description
Mean differences between groups in the average scores of trust in nurses perceived by patients between baseline and the end of follow-up.
Time Frame
6 months
Title
Lifestyle
Description
Mean differences between groups in the average reduction in smoking and alcohol consumption, BMI and in the average increase of consumption of a healthy diet in diabetic patients between baseline and the end of follow-up.
Time Frame
6 months
Title
Contacts with health services
Description
Mean differences between groups in the reduction of the number of contact sand admissions of diabetic patients at health care services, between baseline and the end of follow-up.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
To be elegible, all subjects had to be diabetics (Diabetes Mellitus, Non-Insulin-Dependent)
Speaking and reading italian
Having an active phone number and an email address
Providing a signed a informed consent
Exclusion Criteria:
Mental illness
Hospitalized patients and who refused to partecipate
12. IPD Sharing Statement
Learn more about this trial
Nurse-led Reminder Program for Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients
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