Clinical trial NCT02487589: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Keywords: Falls
Elderly
e-Health
Telemedicine
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 280
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Falls events
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Fondazione Salvatore Maugeri, IRCCS
state: Brescia
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Alessandro Giordano, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.