Clinical trial NCT02074501: Intervention in Informal Caregivers Who Care Older People After a Stroke: a Pilot Study in Northern Portugal
Official title: Supporting Older People's Informal CAREgivers at Home Through InCARE Programme
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Disorder
Keywords: stroke
elderly
caregivers
empowerment
self-care
pilot study
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 158
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

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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.

Primary outcomes:
measure: Empowerment to self-care in informal caregivers
timeFrame: 65 years
Secondary outcomes:
measure: Burden
timeFrame: 65
measure: Health quality of life
timeFrame: 65
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Odete Araújo
state: Norte
Study officials:
affiliation: University of Minho
name: Odete Araújo, PhDs;MSc;RN
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1161/01.str.0000020711.38824.e3.
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. doi: 10.1136/bmj.328.7448.1099.
citation: 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.
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.
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. doi: 10.1111/j.1365-2648.2004.03078.x.
citation: 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.
citation: 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.