Chronic DiseasesNCT02487589
Falls in Elderly and Telehealth: a Randomized Controlled Study
A study testing Telephone support, telemonitoring and tele-exercise in people with Chronic Diseases, run by Fondazione Salvatore Maugeri at 1 site in Italy.
Trial summary
Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programs are effective in all older population studied. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- Telephone support, telemonitoring and tele-exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteItaly
- Study dates
- May 2014to Jun 2016
- 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
- Patients aged 65 years and over
- Patients with a high risk profile (at least one fall event in the last 12 months, Berg scale score ≤ 45 and at least one fall event during in-hospital stay) of recurrent falling
- Patients discharged from the Institute of Fondazione Salvatore Maugeri, IRCCS after a period of rehabilitation and living independently
Who cannot join
- Patients' inability to sign the informed consent
- Patients living in a nursing home
- Patients permanently bedridden or fully dependent on a wheelchair
- Patients with cancer
- Patients with Mini Mental Examination State (MMSE) < 18
- Patients with MMSE < 24 lacking of caregiver at home
- Patients with neurological impairment (i.e. aphasia and neglect)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Cost-effectiveness of a Multidisciplinary Home-telehealth Intervention Programme to Reduce Falls Among Elderly Discharged From Hospital: a Randomized Controlled Trial
Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programs are effective in all older population studied. However, the application of these programs may not be the same in all National health care setting and, consequently, needs to be evacuated by cost-effectiveness studies before to plan this intervention in regular care. In Italy structured collaboration between hospital staff and primary care is generally lacking and the role of Information and Communication Technologies (ICT) in a fall prevention program at home has never been explored.
This is a two-group randomized controlled trial aiming to evaluate the effect of a home-based intervention program, delivered by a multidisciplinary health team, in preventing falls in elderly. The home tele-management program, previously adopted in our Institute for chronic patients, will be proposed to elderly people affected by chronic diseases at high risk of falling at time of hospital discharge. The program will involve the hospital staff and will be managed thanks to the collaboration between hospital and primary care setting. Patients will be followed at home for 6 months after hospital discharge. A nurse-tutor will be the case manager and telephone support, telemonitoring and tele-exercise will characterize the intervention program. People in the control group will receive the usual care. The main outcome measure of the study will be the percentage of patients sustaining a fall during the 6-months follow-up period. An economic evaluation will be performed from a societal perspective and will involve calculating cost-effectiveness and cost utility ratios.
Read the detailed description
The main objective of the study is to evaluate the effects of a home-based intervention program delivered by a multidisciplinary team through available ICT on recurrent falls in elderly discharged from hospital. This objective results in the following research questions:
Is the program more effective than usual care in preventing new falls after hospital discharge?
Is the program cost-effective compared to usual care when assessed from a community perspective?
Besides the effect and economic evaluations, a process evaluation will be carried out to assess the feasibility and the applicability of the program for those receiving and implementing the intervention.
The investigators expect that an intervention program can be effective to reduce falls in elderly patients discharged from hospital. The feasibility of the program for the participants and the cost-effectiveness analysis will confirm whether or a larger national trial is warranted.
- Conditions
- Chronic Diseases
- Being tested
- Telephone support, telemonitoring and tele-exercise
- Keywords
- Falls, Elderly, e-Health, Telemedicine
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone support, telemonitoring and tele-exerciseOther
The care model will provide 24/24 h assistance for six months and include:
Telephone Support: a nurse-tutor (NT) will follow-up the enrolled patients weekly mainly through scheduled appointments. NTs duties will be: 1 education (patients and family ' s health education on how to prevent falls, verification of the adherence to the pharmacological therapy, teaching on how to recognize problems that can conduct to falls) and 2. management. Occasional appointments will be required by patients on duty and managed by a nurse .
Telemonitoring: all patients will send proper biological traces and data will be registered on a personal health record.
Tele-exercise: Home exercises sessions will be provided by a DVD and monitored through a videoconference by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | In Italy, medical risks and patients risk behaviour are not systematically registered and addressed by hospital physicians, specialists and general practitioners (GPs). Patients allocated in control group will receive by the hospital staff tailored recommendations based on their own risk profile. The same information will be sent to their GPs. No restrictions on co-interventions will be placed. |
| Treated group | Experimental | Telephone support, telemonitoring and tele-exercise Receives: Other: Telephone support, telemonitoring and tele-exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls events
The percentage of patients sustaining a fall
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 posted1 Jul 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseasesStudies 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Giordano, Fondazione Salvatore Maugeri
- Investigators
- Alessandro Giordano, MD, Principal investigator, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487589
- Sponsor's protocol ID
- GR-2010-2310662
- Status last verified
- Jun 2016
- First submitted
- 18 Jun 2015
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Giordano A, Bonometti GP, Vanoglio F, Paneroni M, Bernocchi P, Comini L, Giordano A. Feasibility and cost-effectiveness of a multidisciplinary home-telehealth intervention programme to reduce falls among elderly discharged from hospital: study protocol for a randomized controlled trial. BMC Geriatr. 2016 Dec 7;16(1):209. doi: 10.1186/s12877-016-0378-z.
PubMed 27923343
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Cost-effectiveness of a Multidisciplinary Home-telehealth Intervention Programme to Reduce Falls Among Elderly Discharged From Hospital: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02487589
- Acronym / sponsor ID
- GR-2010-2310662
- Conditions
- Chronic Diseases
- Keywords
- Falls, Elderly, e-Health, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Jul 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.
Fall incidents are the third cause of chronic disablement in elderly according to the World Health Organization (WHO). Recent meta-analyses shows that a multifactorial falls risk assessment and management programs are effective in all older population studied. However, the application of these programs may not be the same in all National health care setting and, consequently, needs to be evacuated by cost-effectiveness studies before to plan this intervention in regular care. In Italy structured collaboration between hospital staff and primary care is generally lacking and the role of Information and Communication Technologies (ICT) in a fall prevention program at home has never been explored.
This is a two-group randomized controlled trial aiming to evaluate the effect of a home-based intervention program, delivered by a multidisciplinary health team, in preventing falls in elderly. The home tele-management program, previously adopted in our Institute for chronic patients, will be proposed to elderly people affected by chronic diseases at high risk of falling at time of hospital discharge. The program will involve the hospital staff and will be managed thanks to the collaboration between hospital and primary care setting. Patients will be followed at home for 6 months after hospital discharge. A nurse-tutor will be the case manager and telephone support, telemonitoring and tele-exercise will characterize the intervention program. People in the control group will receive the usual care. The main outcome measure of the study will be the percentage of patients sustaining a fall during the 6-months follow-up period. An economic evaluation will be performed from a societal perspective and will involve calculating cost-effectiveness and cost utility ratios.
Detailed description
The main objective of the study is to evaluate the effects of a home-based intervention program delivered by a multidisciplinary team through available ICT on recurrent falls in elderly discharged from hospital. This objective results in the following research questions:
Is the program more effective than usual care in preventing new falls after hospital discharge?
Is the program cost-effective compared to usual care when assessed from a community perspective?
Besides the effect and economic evaluations, a process evaluation will be carried out to assess the feasibility and the applicability of the program for those receiving and implementing the intervention.
The investigators expect that an intervention program can be effective to reduce falls in elderly patients discharged from hospital. The feasibility of the program for the participants and the cost-effectiveness analysis will confirm whether or a larger national trial is warranted.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –In Italy, medical risks and patients risk behaviour are not systematically registered and addressed by hospital physicians, specialists and general practitioners (GPs). Patients allocated in control group will receive by the hospital staff tailored recommendations based on their own risk profile. The same information will be sent to their GPs. No restrictions on co-interventions will be placed. |
| Treated group | Experimental | Other: Telephone support, telemonitoring and tele-exerciseTelephone support, telemonitoring and tele-exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients aged 65 years and over
- Patients with a high risk profile (at least one fall event in the last 12 months, Berg scale score ≤ 45 and at least one fall event during in-hospital stay) of recurrent falling
- Patients discharged from the Institute of Fondazione Salvatore Maugeri, IRCCS after a period of rehabilitation and living independently
Key exclusion criteria (7 listed)
- Patients' inability to sign the informed consent
- Patients living in a nursing home
- Patients permanently bedridden or fully dependent on a wheelchair
- Patients with cancer
- Patients with Mini Mental Examination State (MMSE) < 18
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 |
|---|---|---|
| Telephone support, telemonitoring and tele-exerciseThe care model will provide 24/24 h assistance for six months and include: Telephone Support: a nurse-tutor (NT) will follow-up the enrolled patients weekly mainly through scheduled appointments. NTs duties will be: 1 education (patients and family ' s health education on how to prevent falls, verification of the adherence to the pharmacological therapy, teaching on how to recognize problems that can conduct to falls) and 2. management. Occasional appointments will be required by patients on duty and managed by a nurse . Telemonitoring: all patients will send proper biological traces and data will be registered on a personal health record. Tele-exercise: Home exercises sessions will be provided by a DVD and monitored through a videoconference by a physiotherapist. | Other | Treated group |
Primary outcome
Falls events
Time frame: 6-months
The percentage of patients sustaining a fall
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 16 Jun 2016.
- Derived from this study: PubMed 27923343Giordano A, Bonometti GP, Vanoglio F, Paneroni M, Bernocchi P, Comini L, Giordano A. Feasibility and cost-effectiveness of a multidisciplinary home-telehealth intervention programme to reduce falls among elderly discharged from hospital: study protocol for a randomized controlled trial. BMC Geriatr. 2016 Dec 7;16(1):209. doi: 10.1186/s12877-016-0378-z.
- Individual participant dataSharing planned: No
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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.
Alessandro Giordano, MD principal investigator
Fondazione Salvatore Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone support, telemonitoring and tele-exercise in people with Chronic Diseases, run by Fondazione Salvatore Maugeri at 1 site 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 3 inclusion and 7 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Falls events (time frame: 6-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 NCT02487589, which also lists 1 linked publication.
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 16 Jun 2016.