Nurse-led Reminder Program for Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

Official title:

The Efficacy of a Nurse-led Reminder Program on Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02196272
• Other study ID #: SAPS-001
• Status: Not yet recruiting
• Phase: N/A
• First received: July 15, 2014
• Last updated: July 18, 2014
• Start date: July 2014

Study information

• Verified date: July 2014
• Source: Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Nurse-led reminder program through email
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	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.	6 months	No
Secondary	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.	6 months	No
Secondary	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.	6 months	No