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

Cerebrovascular Disorder Clinical Trial

— InCARE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02074501
• Other study ID #: 44/2013
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 21, 2014
• Last updated: February 26, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2014
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical 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. 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.

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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 158
• Est. completion date: October 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cerebrovascular Disorder
• Cerebrovascular Disorders

Intervention

Other:
• training capacity in caregivers
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.

Locations

Country	Name	City	State
Portugal	Odete Araújo	Braga	Norte

Sponsors (1)

Lead Sponsor	Collaborator
University of Minho

Country where clinical trial is conducted

Portugal, 

References & Publications (7)

Correia M, Silva MR, Matos I, Magalhães 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. Epub 2004 Jul 15. — View Citation

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. — View Citation

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. — View Citation

Larson J, Franzén-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. — View Citation

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. — View Citation

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. — View Citation

Truelsen T, Piechowski-Józwiak 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	65 years	Yes
Secondary	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.	65	Yes
Secondary	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.	65	Yes