RehospitalizationPhase 3NCT02052401
Domiciliary Intervention by Occupational Therapy to Prevent Elderly Rehospitalization
A Phase 3 study testing Domiciliary Intervention in people with Rehospitalization, run by Comisión Nacional de Investigación Científica y Tecnológica at 2 sites in Chile.
Trial 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 more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Rehospitalization
- What is being tested?
- Domiciliary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesChile
- Study dates
- Feb 2014to Feb 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Estimated survival under 6 months
- Previous Institutionalisation or defined at discharge
- Reference individual with severe hearing problems that could interfere with telephone communication
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital Clinico de la Universidad de Chile
Santiago, Santiago Metropolitan, 8380456
Hospital Fuerza Aérea de Chile
Santiago
About this study
Official title: Domiciliary Intervention by Occupational Therapy After Hospital Discharge, to Prevent Rehospitalization in Elderly: Randomized Clinical Trial
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 .
- Conditions
- Rehospitalization
- Being tested
- Domiciliary Intervention
- Keywords
- OLD AGE, Elderly, Domiciliary Intervention, Occupational Therapy, Rehospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy Intervention | Experimental | Post Discharge Domiciliary Intervention by Occupational Therapy (OT) Receives: Other: Domiciliary Intervention |
| Usual follow-up | No intervention | Usual follow-up of post discharge elderly patients, including pharmacological, and non-pharmacological care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization Rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comisión Nacional de Investigación Científica y Tecnológica
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerardo F Fasce Pineda, MD, University of Chile
- Investigators
- Gerardo Fasce, MD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052401
- Sponsor's protocol ID
- SA13I20184
- Status last verified
- Feb 2016
- First submitted
- 30 Jan 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domiciliary Intervention by Occupational Therapy After Hospital Discharge, to Prevent Rehospitalization in Elderly: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02052401
- Acronym / sponsor ID
- SA13I20184
- Conditions
- Rehospitalization
- Keywords
- OLD AGE, Elderly, Domiciliary Intervention, Occupational Therapy, Rehospitalization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Comisión Nacional de Investigación Científica y TecnológicaOther government
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy Intervention | Experimental | Other: Domiciliary InterventionPost Discharge Domiciliary Intervention by Occupational Therapy (OT) |
| Usual follow-up | No intervention | –Usual follow-up of post discharge elderly patients, including pharmacological, and non-pharmacological care. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Estimated survival under 6 months
- Previous Institutionalisation or defined at discharge
- Reference individual with severe hearing problems that could interfere with telephone communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Domiciliary InterventionTwo 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. | Other | Occupational Therapy Intervention |
Primary outcome
Rehospitalization Rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerardo Fasce, MD principal investigator
University of Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Domiciliary Intervention in people with Rehospitalization, run by Comisión Nacional de Investigación Científica y Tecnológica at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.