Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart FailureNCT01608932
Life-long Monitoring of Frail Patients With Chronic Diseases
A study testing Telemonitoring for frail patients with chronic diseases in people with Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure, run by Regione Veneto at 7 sites in Italy.
Trial summary
The purpose of this study is to evaluate whether telemonitoring of frail patients with chronic diseases produces benefits in terms of reduced readmissions, improved health related quality of life, and improved health status. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure
- What is being tested?
- Telemonitoring for frail patients with chronic diseases
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 7 sitesItaly
- Study dates
- Apr 2012to May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Diagnosis of one or more of the following chronic diseases:
- Heart failure - diagnosis confirmed by echocardiogram or by a specialist assessment
- Type 1 or 2 diabetes - with HbA1C of 7.5 or greater in the previous 15 months
- Chronic Obstructive Pulmonary Disease (COPD) - diagnosis confirmed by spirometry and FEV1 ≤ 70% of predicted normal and/or FEV1/FVC ratio ≤ 70% or by a specialist assessment
- and at least one of the following Social inclusion criteria:
Show all 10Show fewer
- Have had a fall in the previous year or who are considered at high risk of falling
- Need home social care
- Have a caregiver who have difficulties to take care of him/her properly
- Cognitive impairment/confusion, but with caregiver able to use devices.
Who cannot join
- Patient unable to use the telemonitoring equipment (alone and assisted)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Local Health Authority of Mirano
Mirano, Venezia
Local Heath Authority of Padova
Padova, Padova
Local Health Authority of Pieve di Soligo
Pieve di Soligo, Treviso
Local Heath Authority of Thiene
Thiene, Vicenza
Local Health Authority of Treviso
Treviso, Treviso
Local Heath Authority Veneziana
Venezia, Venezia
Local Heath Authority of Verona
Verona, Verona
About this study
Official title: RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region
The purpose of this study is to evaluate whether telemonitoring of frail patients with chronic diseases produces benefits in terms of reduced readmissions, improved health related quality of life, and improved health status. In addition, the trial evaluates the economic and organisational impact of the telemonitoring service and examines its acceptability by patients and health professionals.
Read the detailed description
The study is designed to evaluate the impact of telemonitoring on the follow-up of elderly patients with one or more chronic diseases among heart failure, chronic obstructive pulmonary disease and diabetes. The particular target of patients selected has the particularity of being "frail" according to a set of social eligibility criteria, agreed by the clinicians participating at the study. General practitioners are the first clinicians in charge of managing these patients during the trial follow-up. The term of comparison is represented by a control group, followed by outpatient usual care.
From a clinical point of view, the trial will investigate how the remote monitoring of some clinical parameters contributes to reduce the access to healthcare facilities (emergency and planned hospitalization, bed-days, ER, specialist and GP visits), to improve the patients health-related quality of life and to reduce the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.
- Being tested
- Telemonitoring for frail patients with chronic diseases
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring for frail patients with chronic diseasesProcedure or surgery
Patients are equipped with a telemonitoring kit that can be composed by a portable wrist clinic device, a digital weight scale and a glucometer for clinical parameters measuring, according to the pathologies of the patient. The equipment is completed by a gateway device for data transmission.
The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG, body weight and glycemia with a frequency set by the clinician in the personalized treatment plan. In the same protocol the clinician includes also the alarm thresholds that determine when the clinical measures are out-of-range. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the general practitioner in case of worsening of symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Treatment as usual |
| Telemonitoring for frail patients with chronic diseases | Experimental | Telemonitoring for frail patients with chronic diseases Receives: Procedure: Telemonitoring for frail patients with chronic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of emergency hospitalisations
Measured: 12 months
Secondary outcomes (7)
Number of primary care visits.
Measured: 12 months
Health related quality of life as measured by the SF 36 version 2 questionnaire
Measured: 12 months
All cause mortality
Measured: 12 months
Number of visits to emergency department
Measured: 12 months
Number of elective hospital admissions
Measured: 12 months
Number of bed days for hospitalised patients
Measured: 12 months
Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regione Veneto
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, The European Regional and Local Health Authorities, SIMG (Italian College of General Medicine)
- Responsible party
- Sponsor
- Investigators
- Nicolò Seminara, MD, Principal investigator, SIMG - LHA 9 of Treviso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608932
- Sponsor's protocol ID
- G.A. 250487 - Veneto WP8Cl10
- Status last verified
- May 2012
- First submitted
- 29 May 2012
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region
- ClinicalTrials.gov ID
- NCT01608932
- Acronym / sponsor ID
- G.A. 250487 - Veneto WP8Cl10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Regione VenetoUniversity, hospital or other
- Collaborators
- European Commission, The European Regional and Local Health Authorities, SIMG (Italian College of General Medicine)
- Study start
- Apr 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 31 May 2012 (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.
The purpose of this study is to evaluate whether telemonitoring of frail patients with chronic diseases produces benefits in terms of reduced readmissions, improved health related quality of life, and improved health status. In addition, the trial evaluates the economic and organisational impact of the telemonitoring service and examines its acceptability by patients and health professionals.
Detailed description
The study is designed to evaluate the impact of telemonitoring on the follow-up of elderly patients with one or more chronic diseases among heart failure, chronic obstructive pulmonary disease and diabetes. The particular target of patients selected has the particularity of being "frail" according to a set of social eligibility criteria, agreed by the clinicians participating at the study. General practitioners are the first clinicians in charge of managing these patients during the trial follow-up. The term of comparison is represented by a control group, followed by outpatient usual care.
From a clinical point of view, the trial will investigate how the remote monitoring of some clinical parameters contributes to reduce the access to healthcare facilities (emergency and planned hospitalization, bed-days, ER, specialist and GP visits), to improve the patients health-related quality of life and to reduce the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Treatment as usual |
| Telemonitoring for frail patients with chronic diseases | Experimental | Procedure: Telemonitoring for frail patients with chronic diseasesTelemonitoring for frail patients with chronic diseases |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Age ≥ 65 years
- Diagnosis of one or more of the following chronic diseases:
- and at least one of the following Social inclusion criteria:
Key exclusion criteria (1 listed)
- Patient unable to use the telemonitoring equipment (alone and assisted)
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 |
|---|---|---|
| Telemonitoring for frail patients with chronic diseasesPatients are equipped with a telemonitoring kit that can be composed by a portable wrist clinic device, a digital weight scale and a glucometer for clinical parameters measuring, according to the pathologies of the patient. The equipment is completed by a gateway device for data transmission. The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG, body weight and glycemia with a frequency set by the clinician in the personalized treatment plan. In the same protocol the clinician includes also the alarm thresholds that determine when the clinical measures are out-of-range. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the general practitioner in case of worsening of symptoms. | Procedure or surgery | Telemonitoring for frail patients with chronic diseases |
Primary outcome
Number of emergency hospitalisations
Time frame: 12 months
7 secondary outcomes
Number of primary care visits.
Time frame: 12 months
Health related quality of life as measured by the SF 36 version 2 questionnaire
Time frame: 12 months
All cause mortality
Time frame: 12 months
Number of visits to emergency department
Time frame: 12 months
Number of elective hospital admissions
Time frame: 12 months
Number of bed days for hospitalised patients
Time frame: 12 months
Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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.
Nicolò Seminara, MD principal investigator
SIMG - LHA 9 of Treviso
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring for frail patients with chronic diseases in people with Multiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart Failure, run by Regione Veneto at 7 sites in Italy.
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 10 inclusion and 1 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: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of emergency hospitalisations (time frame: 12 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 28 Oct 2015.