Falls in Elderly and Telehealth: a Randomized Controlled Study

Chronic Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487589
• Other study ID #: GR-2010-2310662
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: June 15, 2016
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

Intervention

Other:
• Telephone support, telemonitoring and tele-exercise
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.

Locations

Country	Name	City	State
Italy	Fondazione Salvatore Maugeri, IRCCS	Lumezzane	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls events	The percentage of patients sustaining a fall	6-months	No