Online Support Program for Dementia Caregivers

NCT04026919 | Unknown DMC

• 1 other identifier: 00423
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Effect Increased

Outcome Measures

Primary Outcomes (1)

• Burden

  Reduced Zarit burden scale (ZBI, Regueiro Pérez, Gómara \& Ferreiro, 2007). It consists of 7 items that measures the perceived burden of caregivers via 5-point Likert scale items (0 = never, 1 = almost never, 2 = sometimes, 3 = many times, and 4 = almost always). This instrument establishes different degrees of overload depending on the score obtained. Scores lower than 17 are indicative that there is no overload, while scores higher than 17 indicate the existence of it.

  Day 0, Month 0 and Day 0, Month 9

Secondary Outcomes (6)

• Memory and behavior problems

  Day 0, Month 0 and Day 0, Month 9

• Health status

  Day 0, Month 0 and Day 0, Month 9

• Anxiety and depression

  Day 0, Month 0 and Day 0, Month 9

• Social support

  Day 0, Month 0 and Day 0, Month 9

• Satisfaction with care

  Day 0, Month 0 and Day 0, Month 9

Study Arms (1)

to analyze the effectiveness of Ok en Casa Zaindoo

EXPERIMENTAL

The multicomponent online programme is composed of the components explained in the detailed study description:

Other: OK EN CASA-ZAINDOO

Interventions

OK EN CASA-ZAINDOO OTHER

Intervention based on cognitive- behavioural techniques offered in an online format.

to analyze the effectiveness of Ok en Casa Zaindoo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• To be the main caregiver of the person with dementia
• To be over 18 years of age
• Provision of at least 6 months of care
• Provide at least one hour of care per day.

You may not qualify if:

• Having a contractual relationship for caring issues with the elderly person with dementia or with its family
• Have a disease that makes participation difficult during this pilot study (18 months)
• Not to have dementia.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (2)

University of the Basque Country

San Sebastián, Guipuzcoa, 20018, Spain

COMPLETED

University of the Basque Country

San Sebastián, Guipuzcoa, 20018, Spain

RECRUITING

Study Officials

• Igone Etxeberria, doctor

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igone Etxeberria, Doctor

CONTACT

+34 653747655; igone.etxeberria@ehu.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The random assignment of the participants was carried out according to the following criteria: 1) Prepare an unpredictable sequence of random numbers; and, 2) Keep this sequence hidden until the assignment was carried out. To hide the sequence, the person in charge of the random assignment was maintained out of the recruitment and pre-treatment evaluation. The assignment was carried out controlling the following variables: sex, age (over or under 60 years), burden (score\> 17 in the Reduced Zarit caregiver burden interview), attendance or not to the SENDIAN program (psychological support users) and / or support groups or non-users) of the primary caregiver and the level of dependence of the elderly person with dementia (mild / moderate or severe).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 19, 2019
• Study Start: September 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)