Alzheimer DiseaseUP-TECHNCT01700556
A Trial to Support Caregivers of Patients With Dementia in Italy: the UP-TECH Project
A study testing Case Manager, Assistive Technologies and light support in people with Alzheimer Disease, run by Istituto Nazionale di Ricovero e Cura per Anziani at 5 sites in Italy.
Trial summary
The UP-TECH project aims at developing an UPgrading quality of care for Alzheimer's disease patients through the integration of services and the use of new TECHnologies in order to also improving the quality of life of their family caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Case Manager, Assistive Technologies and light support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 5 sitesItaly
- Study dates
- 14 Jan 2013to 7 Jun 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with a diagnosis of Alzheimer's Disease
- Mini-Mental State Examination (MMSE) patients score between 10 and 20
- patient living in the community
- presence of family caregiver
Who cannot join
- lack of informed consent from the Alzheimer's patient or caregiver. If the patient has been declared legally incompetent or has a support administrator appointed, informed consent will be requested from a family member or from a person appointed by a judge. In the case of natural incapacitation, verified by Alzheimer Evaluation Unit doctors, consent for the patient will be requested from the primary caregiver;
- the presence of more severe diseases in addition to Alzheimer's or unstable chronic conditions in both the AD patient and the family caregiver, as assessed by the Alzheimer Evaluation Unit and other professionals in the health district-intention of moving out of the health district within 12 months;
- lack of a family caregiver or a caregiver less than 18 years old
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
REGIONAL HEALTH UNIT - MARCHE REGION - AREA 2 (ASUR Marche, Area Vasta 2, Distretto Sanitario Centro Ancona), Italy
Ancona
REGIONAL HEALTH UNIT - MARCHE REGION - AREA 1 (ASUR Marche, Area Vasta 1, Distretto Sanitario Pesaro), Italy
Pesaro
REGIONAL HEALTH UNIT - MARCHE REGION - AREA 4 (ASUR Marche, Area Vasta 4, Distretto Sanitario Fermo), Italy
Porto San Giorgio
REGIONAL HEALTH UNIT-MARCHE REGION-AREA 3 (ASUR Marche, Area Vasta 3, Distretto Sanitario Macerata), Italy
Province of Macerata
REGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5, Distretto Sanitario San Benedetto), Italy
San Benedetto del Tronto
About this study
Official title: A Randomised Controlled Trial to Improve Support Services for Caregivers of Patients With Alzheimer Disease in Italy by UPgrading Quality of Care Through the Integration of Services and the Use of New TECHnologies (The UP-TECH Project)
The UP-TECH project aims at developing an UPgrading quality of care for Alzheimer's disease patients through the integration of services and the use of new TECHnologies in order to also improving the quality of life of their family caregivers.
Read the detailed description
The World Alzheimer Report indicates that, worldwide, there were 35.6 million people with dementia in 2010 and according to forecasts, this figure will reach 65.7 million in 2030 and 115.4 million in 2050. To correctly estimate the impact of the Alzheimer's Disease (AD), it should be considered that it also affects patients' families, on whom the burden of care fall. Not surprisingly, Alzheimer's disease is called a "family illness". Family caregivers of Alzheimer's patients are subject to high levels of stress: this puts them at greater risk of developing mood disorders, depression, insomnia and generally reduces their quality of life. Information technology (IT), telecommunications and electronic equipment applied to the home, can contribute to the improvement of the quality of life of Alzheimer's patients and their caregivers. However, the multidimensionality of this problem not only calls for new services, but also for a greater coordination and integration of existing community health and social care services, of the public, nonprofit and private organizations. The assumption underlying projects integrating health care and social services is to improve coordination of support, thus reducing cost and eliminating waste and inefficiencies and improving health outcomes of the patients assisted. Examples of such initiatives in the literature can be found in the United States (the "Program for All Inclusive Care for the Elderly", Branch et al, 1995), in the United Kingdom (the "Darlington Project", Challis et al, 1991), in Canada (the PRISMA project, Hebert et al, 2010) and in France (the "System for Integrated Care for Older Persons", Beland et al, 2006). Among the tools used in these studies are case management, operator training and the use of IT systems to integrate health care and social services.
Building on these experiences, the UP-TECH project aims at developing innovative methodologies and new simple technologies to improve the effectiveness and efficiency of care for AD patients and their caregivers.
The main objectives of the UP-TECH project are the evaluation of the improvement of the quality of life of family caregivers of people with Alzheimer's disease and the potential delay in institutionalization of these patients.
The overall design of the UP-TECH project will include 450 dyads (AD patient and related caregiver) who will be randomly enrolled in three different types of intervention, defined as
- usual care
- UP Protocol
- UP-TECH Protocol fully described below in the section: Interventions.
- Conditions
- Alzheimer Disease
- Being tested
- Case Manager, Assistive Technologies, light support, 3 preventive home visits by a nurse
- Keywords
- Alzheimer Disease, Family Caregiver, Caregiver Burden, Home Care Services, Assistive Technologies
- Medical subject headings
- Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case ManagerOther
The following support will be provided by a case manager:
At least 3 sessions of individual face-to-face counselling (housing arrangements, disease awareness, problem solving) consisting of an initial and two reinforcing sessions four and eight months after enrollment.
Monthly follow-up telephone calls. Stress management training of the family caregiver and some practical items for management of patient care in the home.
Information about services/aid/certification/subsidies offered by the National Health Service, by municipal social services and by local voluntary organizations. Information on health services, support connecting to GPs and health service units (medical specialists, hospital services) and social services (municipal offices and public offices of any capacity).
Assistive TechnologiesOther
The technologies to be employed are devices already widely used and marketed, are simple to use and do not require high technical expertise for installation and maintenance. The devices will be assigned to subjects in the UP-TECH treatment group after an evaluation of the home, made by the case manager. Such technologies include e.g.: access facilitated telephone, timed drug dispenser, and housing adaptations such as anti-slip strips; home leaving sensors; sensors to detect night falls; Gas and water leak sensors, and automatic lights.
light supportOther
An information package illustrating the range of social and health services available in local community will be created. It will be delivered to the caregiver during home visits by the nurse.
3 preventive home visits by a nurseOther
The dyads will receive three home visits by a specifically trained nurse. Home visits will occur at enrollment and after 6 and 12 months. Each visit will occur with the following steps: telephone contact between the nurse and the family caregiver, a home visit comprising the administration of the UP-TECH questionnaire, counselling/training of the caregiver regarding patient assistance, feeding, ergonomics of the home environment, covers practical aspects of patient assistance, such as daily management of drug treatment, ergonomics of the home environment, stress management and care burden. In order to provide this information to the caregiver, the nurses will receive a specific training course.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 150 patient-caregivers will receive a "light support" in the form of paper brochures and 3 preventive home visits by a nurse Receives: Other: light support; Other: 3 preventive home visits by a nurse |
| UP Protocol | Experimental | 150 patient-caregivers provided with the systematic and comprehensive support of a case manager social worker and receiving 3 preventive home visits by a nurse Receives: Other: Case Manager; Other: 3 preventive home visits by a nurse |
| UP-TECH Protocol | Experimental | 150 patient-caregivers provided with the systematic and comprehensive support of a case manager social worker, receiving an intervention based on assistive technologies and 3 preventive home visits by a nurse Receives: Other: Case Manager; Other: Assistive Technologies; Other: 3 preventive home visits by a nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden Inventory
"Caregiver Burden Inventory" (CBI). A previous Italian study estimated that the level of burden of caregivers living with relatives suffering from Alzheimer type of dementia, as measured by the CBI of Novak et al (1989), is equal to 32.5, with a standard deviation equal to 18 (Marvardi et al, 2005). It is therefore assumed that the planned sample size is large enough to detect an effect on the CBI score as low as 24, with a standard deviation equal to 12, in the treatment group and a null effect in the controls. The statistical power was fixed at 80%, with a 0.05 level of significance and a drop-out rate equal to 15%. A CBI score of 24 coincides with a "sentinel" level beyond which it is suggested that caregivers need to receive additional support from the health and social services.
Measured: one year
Proportion of days spent at home by the AD patient in the past year
This outcome is calculated by subtracting, from the calendar year, the number of days of inpatient hospitalization, emergency room visits with a brief stay in the Intensive Observation Unit and institutionalization in an assisted residence facility, care homes and/or nursing homes. The hypothesis that this outcome is the same in the treated and the untreated populations will be tested. The calculation has been made considering a type 1 error (error α) of 0.05, using a one tailed t-test and assuming a 10% difference between values. Regarding this as the smallest effect of clinical relevance, a sample of 150 patients per treatment group will be adequate considering a statistical power equal to 80% and a drop-out rate equal to 15%.
Measured: one year
Secondary outcomes (2)
Quality of Life Questionnaire, SF12
Quality of life of the Alzheimer patient and his/her caregiver
Measured: one year
Analysis of resource consumption
The use of health care and social services by Alzheimer patients and their family caregivers (analysis of resource use), including: number of interventions, time spent by each social worker for each patient/caregiver dyad, costs of technological devices
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study start14 Jan 2013
- Primary completion7 Jun 2014
- Study completion7 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Marche, REGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5, Distretto Sanitario San Benedetto), Italy
- Responsible party
- Sponsor
- Investigators
- Filippo Masera, Dr, Study chair, Istituto Nazionale di Ricovero e Cura per Anziani (INRCA), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700556
- Sponsor's protocol ID
- INRCA-01-2012
- Acronym
- UP-TECH
- Status last verified
- Jun 2020
- First submitted
- 21 Sep 2012
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
PubMed 33417236Chiatti C, Furneri G, Rimland JM, Demma F, Bonfranceschi F, Cassetta L, Masera F, Cherubini A, Corsonello A, Lattanzio F; UP-TECH research group. The economic impact of moderate stage Alzheimer's disease in Italy: evidence from the UP-TECH randomized trial. Int Psychogeriatr. 2015 Sep;27(9):1563-72. doi: 10.1017/S104161021500040X. Epub 2015 Apr 15.
PubMed 25874654Chiatti C, Masera F, Rimland JM, Cherubini A, Scarpino O, Spazzafumo L, Lattanzio F; UP-TECH research group. The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy: study protocol for a randomized controlled trial. Trials. 2013 May 28;14:155. doi: 10.1186/1745-6215-14-155.
PubMed 23714287
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Improve Support Services for Caregivers of Patients With Alzheimer Disease in Italy by UPgrading Quality of Care Through the Integration of Services and the Use of New TECHnologies (The UP-TECH Project)
- ClinicalTrials.gov ID
- NCT01700556
- Acronym / sponsor ID
- UP-TECH / INRCA-01-2012
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Family Caregiver, Caregiver Burden, Home Care Services, Assistive Technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Regione Marche, REGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5, Distretto Sanitario San Benedetto), Italy
- Study start
- 14 Jan 2013 (actual)
- Primary completion
- 7 Jun 2014 (actual)
- Study completion
- 7 Jun 2014 (actual)
- First posted
- 4 Oct 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 UP-TECH project aims at developing an UPgrading quality of care for Alzheimer's disease patients through the integration of services and the use of new TECHnologies in order to also improving the quality of life of their family caregivers.
Detailed description
The World Alzheimer Report indicates that, worldwide, there were 35.6 million people with dementia in 2010 and according to forecasts, this figure will reach 65.7 million in 2030 and 115.4 million in 2050. To correctly estimate the impact of the Alzheimer's Disease (AD), it should be considered that it also affects patients' families, on whom the burden of care fall. Not surprisingly, Alzheimer's disease is called a "family illness". Family caregivers of Alzheimer's patients are subject to high levels of stress: this puts them at greater risk of developing mood disorders, depression, insomnia and generally reduces their quality of life. Information technology (IT), telecommunications and electronic equipment applied to the home, can contribute to the improvement of the quality of life of Alzheimer's patients and their caregivers. However, the multidimensionality of this problem not only calls for new services, but also for a greater coordination and integration of existing community health and social care services, of the public, nonprofit and private organizations. The assumption underlying projects integrating health care and social services is to improve coordination of support, thus reducing cost and eliminating waste and inefficiencies and improving health outcomes of the patients assisted. Examples of such initiatives in the literature can be found in the United States (the "Program for All Inclusive Care for the Elderly", Branch et al, 1995), in the United Kingdom (the "Darlington Project", Challis et al, 1991), in Canada (the PRISMA project, Hebert et al, 2010) and in France (the "System for Integrated Care for Older Persons", Beland et al, 2006). Among the tools used in these studies are case management, operator training and the use of IT systems to integrate health care and social services.
Building on these experiences, the UP-TECH project aims at developing innovative methodologies and new simple technologies to improve the effectiveness and efficiency of care for AD patients and their caregivers.
The main objectives of the UP-TECH project are the evaluation of the improvement of the quality of life of family caregivers of people with Alzheimer's disease and the potential delay in institutionalization of these patients.
The overall design of the UP-TECH project will include 450 dyads (AD patient and related caregiver) who will be randomly enrolled in three different types of intervention, defined as
- usual care
- UP Protocol
- UP-TECH Protocol fully described below in the section: Interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: light support, Other: 3 preventive home visits by a nurse150 patient-caregivers will receive a "light support" in the form of paper brochures and 3 preventive home visits by a nurse |
| UP Protocol | Experimental | Other: Case Manager, Other: 3 preventive home visits by a nurse150 patient-caregivers provided with the systematic and comprehensive support of a case manager social worker and receiving 3 preventive home visits by a nurse |
| UP-TECH Protocol | Experimental | Other: Case Manager, Other: Assistive Technologies, Other: 3 preventive home visits by a nurse150 patient-caregivers provided with the systematic and comprehensive support of a case manager social worker, receiving an intervention based on assistive technologies and 3 preventive home visits by a nurse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient with a diagnosis of Alzheimer's Disease
- Mini-Mental State Examination (MMSE) patients score between 10 and 20
- patient living in the community
- presence of family caregiver
Key exclusion criteria (3 listed)
- lack of informed consent from the Alzheimer's patient or caregiver. If the patient has been declared legally incompetent or has a support administrator appointed, informed consent will be requested from a family member or from a person appointed by a judge. In the case of natural incapacitation, verified by Alzheimer Evaluation Unit doctors, consent for the patient will be requested from the primary caregiver;
- the presence of more severe diseases in addition to Alzheimer's or unstable chronic conditions in both the AD patient and the family caregiver, as assessed by the Alzheimer Evaluation Unit and other professionals in the health district-intention of moving out of the health district within 12 months;
- lack of a family caregiver or a caregiver less than 18 years old
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 |
|---|---|---|
| Case ManagerThe following support will be provided by a case manager: At least 3 sessions of individual face-to-face counselling (housing arrangements, disease awareness, problem solving) consisting of an initial and two reinforcing sessions four and eight months after enrollment. Monthly follow-up telephone calls. Stress management training of the family caregiver and some practical items for management of patient care in the home. Information about services/aid/certification/subsidies offered by the National Health Service, by municipal social services and by local voluntary organizations. Information on health services, support connecting to GPs and health service units (medical specialists, hospital services) and social services (municipal offices and public offices of any capacity). | Other | UP Protocol, UP-TECH Protocol |
| Assistive TechnologiesThe technologies to be employed are devices already widely used and marketed, are simple to use and do not require high technical expertise for installation and maintenance. The devices will be assigned to subjects in the UP-TECH treatment group after an evaluation of the home, made by the case manager. Such technologies include e.g.: access facilitated telephone, timed drug dispenser, and housing adaptations such as anti-slip strips; home leaving sensors; sensors to detect night falls; Gas and water leak sensors, and automatic lights. | Other | UP-TECH Protocol |
| light supportAn information package illustrating the range of social and health services available in local community will be created. It will be delivered to the caregiver during home visits by the nurse. | Other | Usual Care |
| 3 preventive home visits by a nurseThe dyads will receive three home visits by a specifically trained nurse. Home visits will occur at enrollment and after 6 and 12 months. Each visit will occur with the following steps: telephone contact between the nurse and the family caregiver, a home visit comprising the administration of the UP-TECH questionnaire, counselling/training of the caregiver regarding patient assistance, feeding, ergonomics of the home environment, covers practical aspects of patient assistance, such as daily management of drug treatment, ergonomics of the home environment, stress management and care burden. In order to provide this information to the caregiver, the nurses will receive a specific training course. | Other | UP Protocol, UP-TECH Protocol, Usual Care |
Primary outcome
Caregiver Burden Inventory
Time frame: one year
"Caregiver Burden Inventory" (CBI). A previous Italian study estimated that the level of burden of caregivers living with relatives suffering from Alzheimer type of dementia, as measured by the CBI of Novak et al (1989), is equal to 32.5, with a standard deviation equal to 18 (Marvardi et al, 2005). It is therefore assumed that the planned sample size is large enough to detect an effect on the CBI score as low as 24, with a standard deviation equal to 12, in the treatment group and a null effect in the controls. The statistical power was fixed at 80%, with a 0.05 level of significance and a drop-out rate equal to 15%. A CBI score of 24 coincides with a "sentinel" level beyond which it is suggested that caregivers need to receive additional support from the health and social services.
Proportion of days spent at home by the AD patient in the past year
Time frame: one year
This outcome is calculated by subtracting, from the calendar year, the number of days of inpatient hospitalization, emergency room visits with a brief stay in the Intensive Observation Unit and institutionalization in an assisted residence facility, care homes and/or nursing homes. The hypothesis that this outcome is the same in the treated and the untreated populations will be tested. The calculation has been made considering a type 1 error (error α) of 0.05, using a one tailed t-test and assuming a 10% difference between values. Regarding this as the smallest effect of clinical relevance, a sample of 150 patients per treatment group will be adequate considering a statistical power equal to 80% and a drop-out rate equal to 15%.
2 secondary outcomes
Quality of Life Questionnaire, SF12
Time frame: one year
Analysis of resource consumption
Time frame: one year
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 25 Jun 2020.
- Derived from this study: PubMed 33417236Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
- Derived from this study: PubMed 25874654Chiatti C, Furneri G, Rimland JM, Demma F, Bonfranceschi F, Cassetta L, Masera F, Cherubini A, Corsonello A, Lattanzio F; UP-TECH research group. The economic impact of moderate stage Alzheimer's disease in Italy: evidence from the UP-TECH randomized trial. Int Psychogeriatr. 2015 Sep;27(9):1563-72. doi: 10.1017/S104161021500040X. Epub 2015 Apr 15.
- Derived from this study: PubMed 23714287Chiatti C, Masera F, Rimland JM, Cherubini A, Scarpino O, Spazzafumo L, Lattanzio F; UP-TECH research group. The UP-TECH project, an intervention to support caregivers of Alzheimer's disease patients in Italy: study protocol for a randomized controlled trial. Trials. 2013 May 28;14:155. doi: 10.1186/1745-6215-14-155.
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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.
Filippo Masera, Dr study chair
Istituto Nazionale di Ricovero e Cura per Anziani (INRCA), Italy
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Manager, Assistive Technologies and light support in people with Alzheimer Disease, run by Istituto Nazionale di Ricovero e Cura per Anziani at 5 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 4 inclusion and 3 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 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Caregiver Burden Inventory (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT01700556, which also lists 3 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 25 Jun 2020.