Nursing Home Care Intervention Post Stroke (SHARE)

August 8, 2019 updated by: Hospital de Clinicas de Porto Alegre

Nursing Home Care Educational Intervention for Family Caregivers of Older Adults Post Stroke

Associated with the worsening of functional capacity of older adult and the lack of guidance on how to care of them after stroke, the family caregiver starts to fell burden related to the care, and the quality of life was affected by that burden. Besides that, the older adult began to use more frequently health services and had more hospitalizations by preventable conditionals with adequate care.

The aim of this study is to evaluate the effectiveness of educational interventions of care at home provide by nurses to family caregivers of older adult with stroke after hospital discharge, compared with usual care guidelines or no guidance, in one month follow up. The family caregivers of older adults post stroke with the first functional sequel from the Clinical Hospital of Porto Alegre (HCPA) will participate in the study.

The intervention will involve the systematic monitoring of nurses through home visits (HVs) during one month. Thus, will instrumentalize the family caregiver to care of older adult with stoke according the protocol developed in a research group and the needs of care of them. The control group won't receive the home visits and could have or not the usual care guidelines provide by health services that have access.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Associated with the worsening of functional capacity of older adult and the lack of guidance on how to care of them after stroke, the family caregiver starts to fell burden related to the care and the quality of life was affected by that burden. Besides that, the older adult began to use more frequently health services and had more hospitalizations by preventable conditionals with adequate care.

The aim of this study is to evaluate the effectiveness of educational interventions of care at home provide by nurses to family caregivers of older adult with stroke after hospital discharge, compared with usual care guidelines or no guidance, in one month follow up. The family caregivers of older adults post stroke with the first functional sequel from the Clinical Hospital of Porto Alegre (HCPA) will participate in the study. The randomization will be through the randomization list created by web page randomization.com.

The intervention will involve systematic monitoring of nurses through home visits (HVs) during one month. Thus, will instrumentalize the family caregiver to care of older adult with stoke according the protocol developed in a research group and the needs of care of them. The control group won't receive the HVs and could have or not the usual care guidelines provide by health services that have access.

Will be collect the identification, social and demographics data of the older adults and the caregivers at the moment of hospital discharge. Therefore, will be collect the clinical data of the older adults. After discharge and at the older adult's home, will be realized the first home visit (1ª HV) to all older adults and caregivers included in the study and will be applied to the family caregiver the Caregiver Burden Scale and the instrument WHOQOL-BREF that analyse the quality of life. Also, will be applied the Measure of Functional Independence (MIF) to identify the independence level of the older adults and the needs of care. In this moment, will be randomized by an extern member of research group through telephone contact. After this first HV, the older adults and caregivers included in the intervention group will received more three HVs, until 14, 21 and 30 days after discharge, respectively, by a pair of interventional nurses.

The control group won't receive the home visits by nurses, but could have or not the usual care guidelines provide by health services that have access.

All older adults and caregivers included in the study will received a fifth HV until 60 days after discharge. In this last HV will be applied to family caregiver the Caregiver Burden Scale and the instrument WHOQOL-BREF. In addition, will be applied a questionnaire related older adult's utilization of health services and rehospitalizations during this time and the MIF.

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Family caregivers of older adults from the Special Care Unit - stroke (SCU-Stroke) at the moment of discharge;
  • Older adults with diagnosis of stroke with the first sequel identified by minimum score of 2 points from the ranking scale;
  • Older adults who live until 20 kilometers from HCPA;
  • Caregiver will be a family member with consanguineous relationship or not;
  • Caregiver will be responsible for the most part of the older adult's care;
  • Caregiver without payment;
  • Caregiver with 18 year old or more.

Exclusion Criteria:

  • Older adults who live in a Long Term Care Services;
  • Older adults who will be included in a governmental program for Home Care Service;
  • Caregivers who don't accept receive the HV by nurses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nursing educational intervention
The intervention will consist in three home visits (14, 21, 30 days after discharge) by nurses to family caregivers. The nurses will give verbal information and printed materials related to the care of older adults por stroke.
Other: Nursing educational intervention

The nursing educational intervention by home visits will consist in three home visits by nurses until 14, 21 and 30 days after discharge to the intervention group. The nurses will give verbal information to family caregiver related to the care of elderly with stroke based on protocol with orientation related: information about stroke; emotional support; how to access health services; nutrition; airway; hygiene; positioning and transferring; prevent falls; dress/undress; medications; physiological eliminations; skin care. Furthermore, nurses will give some printed materials that contain orientations related to the care.

The control group could have ou not the usual care guidelines provide by health services that have access.
No Intervention: Usual care
The family caregivers won't receive the home visits and could have or not the usual care guidelines provide by health services that have access.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The family caregiver's burden of care analyzed by Caregiver Burden Scale
Time Frame: 2 months
The family caregiver burden of care will be analyzed by Caregiver Burden Scale.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The family caregiver's quality of life analyzed by instrument WHOQOL-BREF
Time Frame: 2 months
The family caregiver quality of life will be analyzed by instrument WHOQOL-BREF.
2 months
The elderly's functional capacity
Time Frame: 2 months
The elderly functional capacity will be analyzed by the instrument Measure of Functional Independence
2 months
The elderly's health service utilization
Time Frame: 2 months
The elderly health service utilization will be assessed by an questionnaire developed for this study. The answers will be yes or not and analyzed quantitatively.
2 months
The elderly's rehospitalization
Time Frame: 2 months
The elderly rehospitalization will be assessed by an questionnaire developed for this study. The answers will be yes or not and analyzed quantitatively.
2 months
The quality of life of family caregiver with 60 years old or older analyzed by instrument WHOQOL-OLD
Time Frame: 2 months
The family caregiver quality of life will be analyzed by instrument WHOQOL-OLD
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Lisiane MG Paskulin, PhD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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