Chronic DiseaseNCT02447562
Model for the Integral Assessment of Chronic Disease Management Supported in Information Technology and Communication.
A study testing Platform NOMHADchronic and Phone-based care group in people with Chronic Disease, run by Instituto de Investigacion Sanitaria La Fe.
Trial summary
Controlled and Randomized Clinical trial with 3 parallel groups (intervention group with a health platform NOMHADchronic, phone-based care group, usual care group) developed in the Valencia La Fe Health Department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Platform NOMHADchronic and Phone-based care group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to 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 years and older
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old.
- High complexity: according to a combined criteria a) predictive model of Valencia La Fe Health department for hospital resources consumption in next 12 months (probability >95%) and b) risk confirmation by a clinical team with experience on chronic patients management.
- Participants that accept to participate in the study by the informed consent signature
- Participants that don't meet any of the exclusion criteria
Who cannot join
- Age <18 años.
- Participants with cognitive or sensorial difficulties or with insufficient knowledge of one of the 2 official languages of Valencian Community that, according to the healthcare professional, may affect their study participation.
- No residents or temporary residents in the Health Department
- Homeless or participants with high-risk of social exclusion.
- Terminal patients or in palliative care according to the SECPAL (Spanish Society of Palliative Care) criteria .
- Community-dwelling patients
Show all 18Show fewer
- Inability for mobile phone management if there is a caregiver with this capability.
- Participants without a phone line
- Non high-complexity chronic patients according to the recruitment healthcare professional.
- Members of the research team, workers related to the centers implied in the study or any other person directly involved in the study -
- First degree consanguinity or similar affinity with the team members.
- Participants already involved in case management.
- Participants already participating in clinical trials or experimental trials.
- Participants that don't accept to participate in the study or not signing the informed consent
- Participants with a main diagnostic of mental diseases
- Participants with active oncological diagnosis
- Participants already following specific interventions for hemodialysis, organ transplanting, day hospital
- Participants with an infectious chronic disease as unique chronic disease (HIV, BHV (Hepatitis B Virus)…)
About this study
Official title: A Randomized Clinical Trial to Investigate the Management for the Integral Assessment Model of Chronic Disease Supported in Information Technology and Communication.
Controlled and Randomized Clinical trial with 3 parallel groups (intervention group with a health platform NOMHADchronic, phone-based care group, usual care group) developed in the Valencia La Fe Health Department. 495 high-complexity chronic patients will be included according to a combined recruitment based on a risk predictive model plus clinical opinion. Patients will be followed-up during 12 months in order to evaluate health-related quality of life, mortality, health consumption, health direct cost and treatment satisfaction.
- Conditions
- Chronic Disease
- Being tested
- Platform NOMHADchronic, Phone-based care group, Usual care group
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platform NOMHADchronicDevice
Intervention group with a health Platform NOMHADchronic
Phone-based care groupOther
Usual care groupOther
| Study group | Role | What they receive |
|---|---|---|
| G_AH | Active comparator | Usual care group Receives: Other: Usual care group |
| G_SP | Other | Phone-based care Receives: Other: Phone-based care group |
| G_NOMHAD | Experimental | Intervention group with a health platform NOMHADchronic Receives: Device: Platform NOMHADchronic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life according to EuroQoL (5 questions, 3 levels)
Measured: 12 months
Secondary outcomes (9)
Change from Baseline HRQL
Measured: 12 months
Health Related Quality of Life according to EuroQoL EVA
Measured: 12 months
Mortality
Measured: 12 months
Number of emergencies room visits
Measured: 12 months
Number of non-planned hospitalizations
Measured: 12 months
Adverse events causing ER visits or non-planned hospitalization
Measured: continous
Health resources consumption according to total number of ER visits and non-planned hospitalizations
Measured: 12 months
Health direct costs using health resources consumption and unitary cost for each resource.
Measured: 12 months
Treatment satisfaction using an ad hoc Likert questionnaire
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 posted19 May 2015 (estimated)
- Study startJun 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447562
- Sponsor's protocol ID
- GECHRONIC
- Status last verified
- May 2015
- First submitted
- 11 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pomerleau J, Knai C, Nolte E. The burden of chronic disease in Europe. In: Nolte E, McKee M (eds.). Caring for people with chronic conditions: A health system perspective. Maidenhead, Open University Press; 2008.
Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
PubMed 17132052World Population Ageing, 1950-2050, (publicación de las Naciones Unidas, número de venta: E.02.XIII.3) y World Population Ageing, 2007 (publicación de las Naciones Unidas, número de venta: E.07.XIII.5
World Health Organization: Innovative care for chronic conditions: building blocks for action. WHO, Geneva; 2002. Disponible en: http://publications.paho.org/product.php?productid=837&cat=0&page=1 [acceso Enero, 2012
World Health Organization. Global Report. Preventing Chronic Disease: a vital investment. WHO, Geneva; 2005.
Bodenheimer T, Berry-Millett R. Follow the money--controlling expenditures by improving care for patients needing costly services. N Engl J Med. 2009 Oct 15;361(16):1521-3. doi: 10.1056/NEJMp0907185. Epub 2009 Sep 30. No abstract available.
PubMed 19797277Bengoa R, Nuño Solinís R (eds.). Curar y cuidar. Innovación en la gestión de enfermedades crónicas: una guía práctica para avanzar. Barcelona, Masson; 2008
Valdivieso B, Garcia-Sempere A, Sanfelix-Gimeno G, Faubel R, Librero J, Soriano E, Peiro S; GeChronic Group. The effect of telehealth, telephone support or usual care on quality of life, mortality and healthcare utilization in elderly high-risk patients with multiple chronic conditions. A prospective study. Med Clin (Barc). 2018 Oct 23;151(8):308-314. doi: 10.1016/j.medcli.2018.03.013. Epub 2018 Apr 25. English, Spanish.
PubMed 29705155
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Investigate the Management for the Integral Assessment Model of Chronic Disease Supported in Information Technology and Communication.
- ClinicalTrials.gov ID
- NCT02447562
- Acronym / sponsor ID
- GECHRONIC
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 May 2015 (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.
Controlled and Randomized Clinical trial with 3 parallel groups (intervention group with a health platform NOMHADchronic, phone-based care group, usual care group) developed in the Valencia La Fe Health Department. 495 high-complexity chronic patients will be included according to a combined recruitment based on a risk predictive model plus clinical opinion. Patients will be followed-up during 12 months in order to evaluate health-related quality of life, mortality, health consumption, health direct cost and treatment satisfaction.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G_AH | Active comparator | Other: Usual care groupUsual care group |
| G_SP | Other | Other: Phone-based care groupPhone-based care |
| G_NOMHAD | Experimental | Device: Platform NOMHADchronicIntervention group with a health platform NOMHADchronic |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old.
- High complexity: according to a combined criteria a) predictive model of Valencia La Fe Health department for hospital resources consumption in next 12 months (probability >95%) and b) risk confirmation by a clinical team with experience on chronic patients management.
- Participants that accept to participate in the study by the informed consent signature
- Participants that don't meet any of the exclusion criteria
Key exclusion criteria (18 listed)
- Age <18 años.
- Participants with cognitive or sensorial difficulties or with insufficient knowledge of one of the 2 official languages of Valencian Community that, according to the healthcare professional, may affect their study participation.
- No residents or temporary residents in the Health Department
- Homeless or participants with high-risk of social exclusion.
- Terminal patients or in palliative care according to the SECPAL (Spanish Society of Palliative Care) criteria .
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 |
|---|---|---|
| Platform NOMHADchronicIntervention group with a health Platform NOMHADchronic | Device | G_NOMHAD |
| Phone-based care group | Other | G_SP |
| Usual care group | Other | G_AH |
Primary outcome
Health Related Quality of Life according to EuroQoL (5 questions, 3 levels)
Time frame: 12 months
9 secondary outcomes
Change from Baseline HRQL
Time frame: 12 months
Health Related Quality of Life according to EuroQoL EVA
Time frame: 12 months
Mortality
Time frame: 12 months
Number of emergencies room visits
Time frame: 12 months
Number of non-planned hospitalizations
Time frame: 12 months
Adverse events causing ER visits or non-planned hospitalization
Time frame: continous
Health resources consumption according to total number of ER visits and non-planned hospitalizations
Time frame: 12 months
Health direct costs using health resources consumption and unitary cost for each resource.
Time frame: 12 months
Treatment satisfaction using an ad hoc Likert questionnaire
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 19 May 2015.
- BackgroundPomerleau J, Knai C, Nolte E. The burden of chronic disease in Europe. In: Nolte E, McKee M (eds.). Caring for people with chronic conditions: A health system perspective. Maidenhead, Open University Press; 2008.
- Background: PubMed 17132052Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- BackgroundWorld Population Ageing, 1950-2050, (publicación de las Naciones Unidas, número de venta: E.02.XIII.3) y World Population Ageing, 2007 (publicación de las Naciones Unidas, número de venta: E.07.XIII.5
- BackgroundWorld Health Organization: Innovative care for chronic conditions: building blocks for action. WHO, Geneva; 2002. Disponible en: http://publications.paho.org/product.php?productid=837&cat=0&page=1 [acceso Enero, 2012
- BackgroundWorld Health Organization. Global Report. Preventing Chronic Disease: a vital investment. WHO, Geneva; 2005.
- Background: PubMed 19797277Bodenheimer T, Berry-Millett R. Follow the money--controlling expenditures by improving care for patients needing costly services. N Engl J Med. 2009 Oct 15;361(16):1521-3. doi: 10.1056/NEJMp0907185. Epub 2009 Sep 30. No abstract available.
- BackgroundBengoa R, Nuño Solinís R (eds.). Curar y cuidar. Innovación en la gestión de enfermedades crónicas: una guía práctica para avanzar. Barcelona, Masson; 2008
- Derived from this study: PubMed 29705155Valdivieso B, Garcia-Sempere A, Sanfelix-Gimeno G, Faubel R, Librero J, Soriano E, Peiro S; GeChronic Group. The effect of telehealth, telephone support or usual care on quality of life, mortality and healthcare utilization in elderly high-risk patients with multiple chronic conditions. A prospective study. Med Clin (Barc). 2018 Oct 23;151(8):308-314. doi: 10.1016/j.medcli.2018.03.013. Epub 2018 Apr 25. English, Spanish.
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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 Platform NOMHADchronic and Phone-based care group in people with Chronic Disease, run by Instituto de Investigacion Sanitaria La Fe.
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 18 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 19 May 2015. 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?
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?
Health Related Quality of Life according to EuroQoL (5 questions, 3 levels) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02447562, which also lists 8 linked publications.
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 19 May 2015.