CClinicalTrials.gg
CompletedNCT02052401Updated Feb 2, 2016

Domiciliary Intervention by Occupational Therapy to Prevent Elderly Rehospitalization

A Phase 3 interventional study of Domiciliary Intervention in Rehospitalization, sponsored by Comisión Nacional de Investigación Científica y Tecnológica. Completed at 2 sites in Chile. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-02-02.

Sponsored by Comisión Nacional de Investigación Científica y Tecnológica · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether a home visit by an Occupational Therapist is effective in reducing the rehospitalization rates in elderly patients after hospital discharge.

Read the detailed description

Introduction: The hospitalization of the elderly is a frequent event that is associated with complications including loss of functionality, which makes it difficult for the person to reinstate to their original context after discharge, increasing the likelihood of rehospitalization.

Objective : To describe and compare the impact of home-based intervention by Occupational Therapists (OT) in the likelihood of rehospitalization at 6 months versus usual care in persons older than 60 years after discharge.

Design : Randomized controlled trial in medical units of the Hospital Clínico de la Universidad de Chile (HCUCh) and Hospital de la Fuerza Aérea de Chile (HFACH)

Patients: Two hundred and six patients aged 60 years or older admitted for acute or decompensated chronic disease to either HCUCH or HFACH, with a life expectancy greater than 6 months, not institutionalized prior to hospitalization or discharge destination , and provided that they have a person of reference after hospital discharge .

Methods: The control group consists of the usual care regarding post discharge patients, in comparison to the experimental group, which , besides the usual discharge plan, considers a home visit from OT on 2 occasions for 6 months, who will apply the following plan of action: Compliance assessment of pharmacological and non-pharmacological indications, applying a checklist of home safety evaluation and structuring of an occupational routine, education of stimulation strategies, education in recognition of warning signs and proper use of health services. Patients will be recruited between 24 and 48 hours prior to hospital discharge where they will be invited to participate. Informed consent will be retrieved, and demographic information of patients and pre- hospitalization functional backgrounds will be collected during this period, and at discharge by means of Barthel Index (independence / dependence in basic activities of daily living (ADL)), Lawton \& Brody Scale (ADL instrumental), Questionnaire Pfeffer Functional Activities ( FAQ), Confusion Assessment Method (CAM) (delirium at discharge), Pfeiffer Questionnaire (Short Portable Mental Status Questionnaire: SPMSQ ) (cognition), and Geriatrics Cumulative Illness Rating Scale disease ( CIRS -G) (comorbidity). Both groups will receive telephone follow-up at 4, 12 and 24 weeks after hospital discharge with intent to evaluate functionality and rehospitalization. Allocators, medical team giving hospital discharge, pone interviewers, and data analysts will be blind of the intervention allocation.

Expected Results: the home-based intervention after discharge with OT reduce the rate of rehospitalization in at least 40 % at 6 months in people over 60 years compared with usual care .

02

Conditions studied

  • Rehospitalization

Keywords

  • OLD AGE
  • Elderly
  • Domiciliary Intervention
  • Occupational Therapy
  • Rehospitalization
03

In context

Lead sponsor

Comisión Nacional de Investigación Científica y Tecnológica is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 60 or older
  • Living close by to domiciliary intervention occupational therapy team
  • Hospitalised in Medical Unit for acute illness or complicated chronic disease
  • Presence of a reference individual, over 18 years old, able to understand recommendations, with contact telephone number, and that shares SPENDS at least 20 hours with patient.
  • Signed informed consent by patient

Exclusion criteria

Exclusion Criteria:

  • Estimated survival under 6 months
  • Previous Institutionalisation or defined at discharge
  • Reference individual with severe hearing problems that could interfere with telephone communication
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
206 participants (actual)

Study arms

  • Experimental
    Occupational Therapy Intervention

    Post Discharge Domiciliary Intervention by Occupational Therapy (OT)

    Other: Domiciliary Intervention

  • No intervention
    Usual follow-up

    Usual follow-up of post discharge elderly patients, including pharmacological, and non-pharmacological care.

Interventions

  • OtherDomiciliary Intervention

    Two time domiciliary application of an standardized protocol consisting of: a) evaluation of pharmacological and non pharmacological therapies adherence. b) application of a Checklist of home safety measures. c) development of a patient oriented occupational routine d) education in strategies for elderly global stimulation e) education strategies for identifying red flags and for correct use of health services.

06

What researchers measure

Primary outcomes

  1. Rehospitalization Rate

    Time frame: 6 months

07

Study locations

2 sites
  • Hospital Clinico de la Universidad de Chile
    Santiago, Region Metropolitana 8380456, Chile
  • Hospital Fuerza Aérea de Chile
    Santiago, Chile
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02052401
Lead sponsor
Comisión Nacional de Investigación Científica y Tecnológica
Responsible party
Gerardo F Fasce Pineda, MD (Medical Doctor, University of Chile) — Principal investigator
First posted
Feb 3, 2014
Start date
Feb 2014
Primary completion
Oct 2015
Completion
Feb 2016
Last update
Feb 2, 2016

Study contacts

Gerardo Fasce, MD
principal investigator · University of Chile

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Comisión Nacional de Investigación Científica y Tecnológica

Start the discussion