search
Back to results

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
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Non-Insulin-Dependent

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 15, 2014
    Last Updated
    July 18, 2014
    Sponsor
    Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
    search

    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

    We'll reach out to this number within 24 hrs