Falls in Elderly and Telehealth: a Randomized Controlled Study
Primary Purpose
Chronic Diseases
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Telephone support, telemonitoring and tele-exercise
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Diseases focused on measuring Falls, Elderly, e-Health, Telemedicine
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Fondazione Salvatore Maugeri, IRCCS
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Treated group
Arm Description
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.
Telephone support, telemonitoring and tele-exercise
Outcomes
Primary Outcome Measures
Falls events
The percentage of patients sustaining a fall
Secondary Outcome Measures
Full Information
NCT ID
NCT02487589
First Posted
June 18, 2015
Last Updated
June 15, 2016
Sponsor
Fondazione Salvatore Maugeri
1. Study Identification
Unique Protocol Identification Number
NCT02487589
Brief Title
Falls in Elderly and Telehealth: a Randomized Controlled 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Salvatore Maugeri
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases
Keywords
Falls, Elderly, e-Health, Telemedicine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Treated group
Arm Type
Experimental
Arm Description
Telephone support, telemonitoring and tele-exercise
Intervention Type
Other
Intervention Name(s)
Telephone support, telemonitoring and tele-exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Falls events
Description
The percentage of patients sustaining a fall
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Giordano, MD
Organizational Affiliation
Fondazione Salvatore Maugeri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Salvatore Maugeri, IRCCS
City
Lumezzane
State/Province
Brescia
ZIP/Postal Code
25065
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27923343
Citation
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.
Results Reference
derived
Learn more about this trial
Falls in Elderly and Telehealth: a Randomized Controlled Study
We'll reach out to this number within 24 hrs