AzTrials
AzTrials

Cerebrovascular DisorderInCARENCT02074501

Intervention in Informal Caregivers Who Care Older People After a Stroke: a Pilot Study in Northern Portugal

A study testing training capacity in caregivers in people with Cerebrovascular Disorder, run by University of Minho at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Background: More than 42% of older people (aged +65) have a stroke and most of them require some type of help to self-care at home. Informal caregivers have reported different types of need and have shown dissatisfaction with technical and emotional support delivered by community health teams. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Cerebrovascular Disorder
What is being tested?
training capacity in caregivers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 sitePortugal
Study dates
Jan 2014to Oct 2014
Phase
Interventional
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Informal caregivers are eligible to participate in the InCARE programme if they meet the following inclusion criteria: (i) to be able to communicate and learn (2) not to have a cognitive disease; (3) to live in the Cávado Region covered by ACES I, II and III; (4) to return the informed consent. In addition, older stroke survivors will enter in this study if they had a stroke for the 1st time and which have become dependent for activities of daily living.
  • -

Who cannot join

  • Involvement in the InCARE programme requires to communicate frequently, face to face or on the phone, with the nursing staff. Informal caregivers will also be excluded in all the situations in which the provision of older people care is taken by formal support.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Odete Araújo

    Braga, Norte, 4755-577

Other trials in Portugal

About this study

Official title: Supporting Older People's Informal CAREgivers at Home Through InCARE Programme

Background: More than 42% of older people (aged +65) have a stroke and most of them require some type of help to self-care at home. Informal caregivers have reported different types of need and have shown dissatisfaction with technical and emotional support delivered by community health teams. Furthermore, empowering informal caregivers who care after older stroke survivors is an important challenge, preventing them from negative outcomes such as burden, anxiety and depression or loss of physical function or hospitalization in older people.

Objectives: This pilot study aims to implement and evaluate the impact of an intervention based on training and telephone support delivered to informal caregivers who care after older people post-stroke.

Read more

Setting: Community health units in Northern Portugal region. Design/Methods: This single blinded randomized trial will be delivered by a community nursing team to informal caregivers 1 week, 1 and 3 months after a hospital discharge.

Study outcome(s): The primary outcomes will be informal caregivers´ empowerment. Secondary outcomes will include burden and health quality of life in caregivers; functionality, hospital readmission and institutionalization of older people stroke survivors, measured 1 and 3 months after intervention.

Results/Conclusion: Data collection started in February and will be concluded in August 2014. First results will be published at the beginning of 2015. The InCARE programme will be the first pilot in informal caregivers study ever conducted in Portugal. It will highlight new ways to support caregivers who take care of older people after a stroke. If successful, this study will be translational and it will also allow to disseminate the results in Portugal and abroad and implement it as best practice.

Read the detailed description

InCare study has a purpose to implement and evaluate an intervention delivered to informal caregivers who care for older people after a stroke.

Being tested
training capacity in caregivers
Keywords
stroke, elderly, caregivers, empowerment, self-care, pilot study
Medical subject headings
Cerebrovascular Disorders, Stroke, Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • training capacity in caregiversOther

    The participants of the InCARE programme (intervention group) will receive, additionally, intervention based on: (i) empowering caregivers to put "hands on" caring, which will be the key-point of the pilot programme; (ii) training handling techniques: mobility, bathing, (un)dressing, transferring, positioning, eating and drinking using technical aids, after 1 week, 1 month and 3 months, post hospital discharge.

Study groups in NCT02074501
Study groupRoleWhat they receive
training capacity in caregiversOtherThe participants of the InCARE programme (intervention group) will receive, additionally, intervention based on: (i) empowering caregivers to put "hands on" caring, which will be the key-point of the pilot programme; (ii) training handling techniques: mobility, bathing, (un)dressing, transferring, positioning, eating and drinking using technical aids, after 1 week, 1 month and 3 months, post hospital discharge; (iii) using telephone support, counselling caregivers on 3rd, 6th, 8th and 10th weeks post discharge. It aims at facilitating the caregivers 'adjustment to stroke demands, increasing knowledge and practical skills to support their decision-making.
Receives: Other: training capacity in caregivers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Empowerment to self-care in informal caregivers

    The primary outcomes will be informal caregivers´ empowerment to self-care. measured by ECPICID-AVC tool. This outcome will be measure 1 week and 1 month post discharge at home.

    The primary analysis will be performed according to the intention-to-treat principle.

    Measured: 65 years

Secondary outcomes (2)

  1. Burden

    Secondary outcomes will include Burden measure by QUASCI tool in informal caregivers. This outcome will be measured 1 and 3 months after InCARE programme. All participants will be recruited through the community staff.

    This study will include a sample size of 79 informal caregivers and stroke survivors for each group.

    The descriptive statistics will describe the participants' characteristics through SPSS software.

    Measured: 65

  2. Health quality of life

    Secondary outcomes will include Health quality of life measure by SF-36 tool in informal caregivers. This outcome will be measured 1 and 3 months after InCARE programme. All participants will be recruited through the community staff.

    This study will include a sample size of 79 informal caregivers and stroke survivors for each group.

    The descriptive statistics will describe the participants' characteristics through SPSS software.

    Measured: 65

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionFeb 2014
  4. Study completionOct 2014 (estimated)

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Care provider
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02074501
Sponsor's protocol ID
44/2013
Acronym
InCARE
Status last verified
Feb 2014
First submitted
21 Feb 2014
Last updated
28 Feb 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Grant JS, Elliott TR, Weaver M, Bartolucci AA, Giger JN. Telephone intervention with family caregivers of stroke survivors after rehabilitation. Stroke. 2002 Aug;33(8):2060-5. doi: 10.1161/01.str.0000020711.38824.e3.

    PubMed 12154263

  • Kalra L, Evans A, Perez I, Melbourn A, Patel A, Knapp M, Donaldson N. Training carers of stroke patients: randomised controlled trial. BMJ. 2004 May 8;328(7448):1099. doi: 10.1136/bmj.328.7448.1099.

    PubMed 15130977

  • Larson J, Franzen-Dahlin A, Billing E, Arbin M, Murray V, Wredling R. The impact of a nurse-led support and education programme for spouses of stroke patients: a randomized controlled trial. J Clin Nurs. 2005 Sep;14(8):995-1003. doi: 10.1111/j.1365-2702.2005.01206.x.

    PubMed 16102151

  • Marsden D, Quinn R, Pond N, Golledge R, Neilson C, White J, McElduff P, Pollack M. A multidisciplinary group programme in rural settings for community-dwelling chronic stroke survivors and their carers: a pilot randomized controlled trial. Clin Rehabil. 2010 Apr;24(4):328-41. doi: 10.1177/0269215509344268. Epub 2010 Feb 22.

    PubMed 20176772

  • McBride KL, White CL, Sourial R, Mayo N. Postdischarge nursing interventions for stroke survivors and their families. J Adv Nurs. 2004 Jul;47(2):192-200. doi: 10.1111/j.1365-2648.2004.03078.x.

    PubMed 15196193

  • Truelsen T, Piechowski-Jozwiak B, Bonita R, Mathers C, Bogousslavsky J, Boysen G. Stroke incidence and prevalence in Europe: a review of available data. Eur J Neurol. 2006 Jun;13(6):581-98. doi: 10.1111/j.1468-1331.2006.01138.x.

    PubMed 16796582

  • Correia M, Silva MR, Matos I, Magalhaes R, Lopes JC, Ferro JM, Silva MC. Prospective community-based study of stroke in Northern Portugal: incidence and case fatality in rural and urban populations. Stroke. 2004 Sep;35(9):2048-53. doi: 10.1161/01.STR.0000137606.34301.13. Epub 2004 Jul 15.

    PubMed 15256683

Questions about this trial

What is this clinical trial studying?

A study testing training capacity in caregivers in people with Cerebrovascular Disorder, run by University of Minho at 1 site in Portugal.

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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. 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.

Are results available for this study?

Results are not available in the source record.

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?

Empowerment to self-care in informal caregivers (time frame: 65 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02074501, which also lists 7 linked publications.

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 28 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in