NCT02052401

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 2, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

January 30, 2014

Last Update Submit

February 1, 2016

Conditions

Rehospitalization

Keywords

OLD AGEElderlyDomiciliary InterventionOccupational TherapyRehospitalization

Outcome Measures

Primary Outcomes (1)

  • Rehospitalization Rate

    6 months

Study Arms (2)

Occupational Therapy Intervention

EXPERIMENTAL

Post Discharge Domiciliary Intervention by Occupational Therapy (OT)

Other: Domiciliary Intervention

Usual follow-up

NO INTERVENTION

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

Interventions

Domiciliary InterventionOTHER

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.

Occupational Therapy Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clinico de la Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Location

Hospital Fuerza Aérea de Chile

Santiago, Chile

Location

Study Officials

  • Gerardo Fasce, MD

    University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 3, 2014

Study Start

February 1, 2014

Primary Completion

October 1, 2015

Study Completion

February 1, 2016

Last Updated

February 2, 2016

Record last verified: 2016-02

Locations

CL(2)