Diabetes Mellitus, Non-Insulin-DependentNCT02196272
Nurse-led Reminder Program for Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients
A study testing Nurse-led reminder program through email in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- Nurse-led reminder program through email
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Mental illness
- Hospitalized patients and who refused to partecipate
About this study
Official title: The Efficacy of a Nurse-led Reminder Program on Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients.
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.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- Nurse-led reminder program through email
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led reminder program through emailBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Nurse-led reminder program through email |
| Management of diabetic patients | No intervention | Usual care, educational program and usual management of Diabetic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giancarlo Cicolini, Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196272
- Sponsor's protocol ID
- SAPS-001
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Nurse-led Reminder Program on Therapy Adherence, Clinical Outcomes and Trust in Nurses in Diabetic Patients.
- ClinicalTrials.gov ID
- NCT02196272
- Acronym / sponsor ID
- SAPS-001
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale n. 2 - Lanciano Vasto ChietiUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2014 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led email program through email | Experimental | Behavioral: Nurse-led reminder program through emailIn addition to usual care and educational program, the intervention group will also receive email alerts and phone calls from the nurse care manager (NCM). |
| Management of diabetic patients | No intervention | –Usual care, educational program and usual management of Diabetic patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Mental illness
- Hospitalized patients and who refused to partecipate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led reminder program through emailBoth 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. | Behavioural | Nurse-led email program through email |
Primary outcome
Medication adherence
Time frame: 6 months
The main outcome of the study was the improvement of medication adherence in diabetic patients between baseline and the end of follow-up.
3 secondary outcomes
Trust in nurses
Time frame: 6 months
Lifestyle
Time frame: 6 months
Contacts with health services
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led reminder program through email in people with Diabetes Mellitus, Non-Insulin-Dependent, run by Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.