NCT02807012

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

June 3, 2016

Last Update Submit

August 8, 2019

Conditions

Stroke

Keywords

Home care servicesNursingClinical trialGeriatric nursingFamily caregiverAged

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • The family caregiver's quality of life analyzed by instrument WHOQOL-BREF

    2 months

  • The elderly's functional capacity

    2 months

  • The elderly's health service utilization

    2 months

  • The elderly's rehospitalization

    2 months

  • The quality of life of family caregiver with 60 years old or older analyzed by instrument WHOQOL-OLD

    2 months

Study Arms (2)

Nursing educational intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Nursing educational interventionOTHER

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.

Nursing educational intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (5)

  • Bierhals CCBK, Dal Pizzol FLF, Low G, Day CB, Santos NOD, Paskulin LMG. Quality of life in caregivers of aged stroke survivors in southern Brazil: Arandomized clinical trial. Rev Lat Am Enfermagem. 2023 Jan-Dec;31:e3657. doi: 10.1590/1518-8345.5935.3657.

    PMID: 36722630DERIVED

  • Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

    PMID: 34813082DERIVED

  • Day CB, Bierhals CCBK, Mocellin D, Predebon ML, Santos NO, Dal Pizzol FLF, Fuhrmann AC, Aires M, Paskulin LMG. Nursing Home Care Intervention Post Stroke (SHARE) 1 year effect on the burden of family caregivers for older adults in Brazil: A randomized controlled trial. Health Soc Care Community. 2021 Jan;29(1):56-65. doi: 10.1111/hsc.13068. Epub 2020 Jun 30.

    PMID: 32602588DERIVED

  • Bierhals CCBK, Day CB, Mocellin D, Santos NOD, Predebon ML, Pizzol FLFD, Fuhrmann AC, Medeiros GG, Aires M, Paskulin LMG. Use of health services by elderly people post-stroke: a randomized controlled trial. Rev Gaucha Enferm. 2019 Dec 2;41(spe):e20190138. doi: 10.1590/1983-1447.2020.20190138. eCollection 2020. English, Portuguese.

    PMID: 31800798DERIVED

  • Day CB, Bierhals CCBK, Santos NOD, Mocellin D, Predebon ML, Dal Pizzol FLF, Paskulin LMG. Nursing home care educational intervention for family caregivers of older adults post stroke (SHARE): study protocol for a randomised trial. Trials. 2018 Feb 9;19(1):96. doi: 10.1186/s13063-018-2454-5.

    PMID: 29426361DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Lisiane MG Paskulin, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 21, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2020

Last Updated

August 12, 2019

Record last verified: 2019-03

Locations

BR(1)