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Status unknownNCT02807012SHAREUpdated Aug 12, 2019

Nursing Home Care Intervention Post Stroke

An interventional study of Nursing educational intervention in Stroke, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-12.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • Home care services
  • Nursing
  • Clinical trial
  • Geriatric nursing
  • Family caregiver
  • Aged
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 82 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
82 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherNursing 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.

06

What researchers measure

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.

    Time frame: 2 months

Secondary outcomes

  1. 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.

    Time frame: 2 months

  2. The elderly's functional capacity

    The elderly functional capacity will be analyzed by the instrument Measure of Functional Independence

    Time frame: 2 months

  3. 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.

    Time frame: 2 months

  4. 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.

    Time frame: 2 months

  5. 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

    Time frame: 2 months

07

Study locations

1 site
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande Do Sul 90035-903, Brazil
08

References and documents

Publications

  • 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. PubMed 34813082 ↗
  • 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. PubMed 32602588 ↗
  • 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. PubMed 31800798 ↗
  • 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. PubMed 29426361 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02807012
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Jun 21, 2016
Start date
May 2016
Primary completion
Jul 2018
Completion
Jul 2020 (estimated)
Last update
Aug 12, 2019

Study contacts

Lisiane MG Paskulin, PhD
principal investigator · Hospital de Clínicas de Porto Alegre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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