Falls in Elderly and Telehealth: a Randomized Controlled Study

NCT02487589 | Completed

• 1 other identifier: GR-2010-2310662
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Diseases

Keywords

Falls; Elderly; e-Health; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Falls events

  The percentage of patients sustaining a fall

  6-months

Study Arms (2)

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

Other: Telephone support, telemonitoring and tele-exercise

Interventions

Telephone support, telemonitoring and tele-exercise OTHER

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.

Treated group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (1)

Fondazione Salvatore Maugeri, IRCCS

Lumezzane, Brescia, 25065, Italy

Location

Related Publications (1)

• 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.

  PMID: 27923343 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandro Giordano, MD

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: July 1, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)