Effect Increased Clinical Trial
Official title:
OK en Casa - ZAINDOO an Online Support Program for Caregivers of People With Dementia, a Randomized Controlled Trial.
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).
Aim: to analyze the effectiveness of a multicomponent online program on primary and secondary
caregivers of a person with dementia.
Methods and analyses: The trial design is a two group randomized controlled trial to
establish the effectiveness of an online support program. The experimental group will
complete the program for 9 months and the control group will continue with their usual
lifestyle. The objective is to examine the effect of this online support program on burden as
primary outcome. Secondary outcomes of the study are social support, perceived health,
anxiety, depression, satisfaction with caregiving, stress derived from the memory and
behaviour problems of the person with dementia and satisfaction with treatment. The
intervention will last for 9 months in total and includes two measurements, pre and post
measure (9 months after) for the experimental and control group. The trial is set in Spain,
concretely in The Basque Country.
OK en casa - Zaindoo: online support program for caregivers of persons with dementia. The
multicomponent online programme is composed of the following components:
Assessment: In this section are placed the assessment tools that the caregiver must complet
online before and after the intervention. The questionnaires collect information regarding
the care context, health (perceived health, depression and anxiety), burden, satisfaction
with care, family support and formal support (instrument created ad hoc).
My status: It offers information and feedback on the context of care, health and the
socio-emotional status of the caregiver. It is composed of six blocks (context of care,
health, burden, satisfaction with care, family support and formal support). The information
offered to the caregiver is based on a system of colours that oscillates between green
(optimal situation) and red (critical situation). Thus, and for each of the blocks indicated
above, if the caregiver is in an optimal state or have few difficulties the green colour is
shown. If has mild symptoms or difficulties in the care context the yellow colour is shown,
the orange would represent moderate symptoms and difficulties and finally, the red colour is
indicative of a critical socio-emotional situation or serious difficulties in the context of
care. Likewise, a single colour is shown as a summary that reflects the general situation of
the caregiver, respecting the order of the colours that have been explained above. The colour
corresponding to each of the blocks and the one regarding the general situation is
accompanied by a text that summarizes caregivers situation using a positive language.
PSYCHOSOCIAL INTERVENTION: Psychoeducational programme: In this section, the caregiver is
recommended a personal plan of structured psychoeducational activities. These activities had
been organized from lesser to greater difficulty and in their design and development the care
phase in which the caregiver is has been taken into account (acquisition, consolidation or
resolution). The activities are different depending on the type of caregiver: primary or
secondary. The aim is to train the caregivers in psychological strategies and skills to face
the care in the most optimal way possible (self-instructions, relaxation techniques, training
in communication skills, problem behaviour management, emotion regulation). The activities
are also aimed at focusing on the positive aspects related to care.
Online-training: In addition to the psychoeducational activities and based on an e-learning
format, the caregiver is offered the possibility to make a personalized online training based
on the evaluation made previously. These are videos with content created ad hoc for the study
and dealing with various aspects related to the care of the person with dementia and the
caregivers self-care.
Psychosocial support: It includes online psychosocial support with specialized psychologists.
A total of 8 online support sessions are arranged, 6 of the appointments are set in advance
and the caregiver is given the option of contacting another 2 times according to their own
needs.
Social networking: each caregiver can interact with other caregivers through a chat. In
addition, they can include reading material related to the care that can be discussed in the
forum.
WALL: It is a space in which various messages are published daily, in some cases
inspirational (i. e. motivating messages), in other cases reminder messages are sent to the
caregiver (i. e. reminder of an appointment with the psychologist) and also auto -promotional
(i. e. move the caregiver to do things for their own benefit). Messages of support sent by
famous people or recognized by the community are also published, testimonies of other
caregivers, and divulgation articles also appear. The main objective is to offer motivating
social support and emotional support to the caregiver.
CARE TEAM AND CHAT: This is the place where the profile of each of the members of the care
team is created, that is the primary and secondary caregivers of the person with dementia. In
addition, a chat is included to exchange information about the cared person, for example,
appointments with health personnel, social workers, incidents in care, medication
modifications, patient's condition, etc.
ORGANIZATION: This element is set up to facilitate the care of the person with dementia. An
appointment calendar is shown on the screen (doctors, nurse, social worker, lawyer, etc.).
There is a repository where documents can be attached with the aim of facilitating
communication between all the members of the care team. This is an organization system shared
by the care team, so that both the primary caregiver and the secondary caregivers have access
to the organization system.
POINTS PROGRAM: The caregiver receives a series of points for performing various actions,
such as, for example, online training, etc. These points can be exchanged for various
services related to health and self-care (for example, massages, tickets for a
thalassotherapy center, discounts, etc.).
ACHIEVEMENT MARKER (1-15): Based on an intermittent reinforcement the caregiver reaches some
achievements, but he does not always know what he has done to get it.
LEVEL MARKER: Indicates the level of the caregiver according to the progress he or she is
making. It ranges between 1 (lower level) and 5 (higher level). In addition, informs about
how much is missing to pass the level.
Randomization 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). Therefore, a stratified randomization was carried out, which is
more appropriate than simple randomization when the sample size is not very large. The
randomization unit were the families.
The precise randomization procedure consisted of ordering the participants according to the
controlled variables and, by means of a sequence of random numbers, the participants were
assigned to the treatment group or to the control group on the waiting list. Due to random it
is possible that the size of the groups will be not exactly the same.
Procedure Sample recruitment Family caregivers of people with dementia were recruited via
information letters and flyers through relevant institutions (San Sebastian City Council,
basic social services, BetiOn (tele-assistance service of the Basque Government), social
services of the Provincial Council of Gipuzkoa, health centers, pharmacies of Donostia, and
the Association of Relatives and Friends of Persons with Alzheimer and other dementias of
Guipuzcoa (AFAGI). Both the letters and the flyers provided a contact telephone associated
with a call center in which calls were received from families interested in participating.
The person in the call center answered the family's call, the possible questions they had,
and if were interested to participate, the person in the call center collected the necessary
data to check if they met with the inclusion and exclusion criteria. Afterwards the project
team analyzed each case, and if complying with inclusion criteria the family was finally
included in the study (primary caregiver and secondary caregivers).
Pre-Measurement It was performed online at the home of the caregivers with the support of
students of the Social Work degree specifically trained to collect data. During this visit,
informed consent was first collected and the pre-treatment evaluation was subsequently
carried out using the evaluation protocol established. The students helped the caregivers to
complete the evaluation protocol online (Tablet or Smartphone). It is hoped that they will
learn to perform the evaluation without help on the next occasion.
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