NCT02196272

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

Same day

First QC Date

July 15, 2014

Last Update Submit

July 18, 2014

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Trust in nurses

    6 months

  • Lifestyle

    6 months

  • Contacts with health services

    6 months

Study Arms (2)

Nurse-led email program through email

EXPERIMENTAL

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).

Behavioral: Nurse-led reminder program through email

Management of diabetic patients

NO INTERVENTION

Usual care, educational program and usual management of Diabetic patients

Interventions

Nurse-led reminder program through emailBEHAVIORAL

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.

Nurse-led email program through email

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Mental illness
  • Hospitalized patients and who refused to partecipate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 22, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2014

Last Updated

July 22, 2014

Record last verified: 2014-07