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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02807012
Other study ID # 16-0181
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date July 2020

Study information

Verified date March 2019
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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 (1ยช 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 82
Est. completion date July 2020
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary The family caregiver's burden of care analyzed by Caregiver Burden Scale The family caregiver burden of care will be analyzed by Caregiver Burden Scale. 2 months
Secondary The family caregiver's quality of life analyzed by instrument WHOQOL-BREF The family caregiver quality of life will be analyzed by instrument WHOQOL-BREF. 2 months
Secondary The elderly's functional capacity The elderly functional capacity will be analyzed by the instrument Measure of Functional Independence 2 months
Secondary The elderly's health service utilization 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
Secondary The elderly's rehospitalization 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
Secondary The quality of life of family caregiver with 60 years old or older analyzed by instrument WHOQOL-OLD The family caregiver quality of life will be analyzed by instrument WHOQOL-OLD 2 months
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