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NCT04026919: OKenCASA

Online Support Program for Dementia Caregivers

Status unknown NA Last updated 19 July 2019
What this trial tests

NA trial testing OK EN CASA-ZAINDOO in Effect Increased in 250 participants. Status unknown.

Timeline
1 September 2018
Primary endpoint
1 March 2020
1 March 2020

Quick facts

Lead sponsorUniversity of the Basque Country (UPV/EHU)
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment250
Start date1 September 2018
Primary completion1 March 2020
Estimated completion1 March 2020
Sites2 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

University of the Basque Country (UPV/EHU)

Who can join

Eligibility, any sex, with Effect Increased. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There are currently 50 million people in the world diagnosed with dementia. Due to the detrimental impact on the mental and physical health of family caregivers different online interventions have been developed in order to improve their well-being. In this paper, we describe the design of a randomized controlled trial aiming to study the impact of a multicomponent online program on primary and secondary caregivers of a person with dementia (PWD). The experimental group will receive the intervention which is a multicomponent program based on different components, among others; online psychoeducation, training on psychological skills, a forum with other caregivers and interaction with a psychologist. Caregivers in the control group will follow their lifestyle. More than 250 participants (primary and secondary caregivers) are expected to be recruited via several sources in the province of Guipuzcoa in Spain. The inclusion criteria for the primary caregiver are: a) being 18 years or older; b) being the primary caregiver of the PWD; c) more than 6 months caring; and d) give more than 1 hour of caregiving per day. The outcomes of this trial are caregiver burden (primary outcome), perceived health, depression and anxiety, social support, satisfaction with care and with the treatment and stress caused by the problem behaviour of the PWD (secondary outcomes).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Remotely delivered information, training and support for informal caregivers of people with dementia.
    González-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozúa B, et al · · 2021 · cited 54× · PMID 33417236 · DOI 10.1002/14651858.cd006440.pub3

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