Clinical trial NCT06326151: Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults
Official title: Study for a Randomised Controlled Trial: Effect of an Interdisciplinary Psycho-educational Intervention Programme on Caregivers of Dependent Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dependent Older People
Family Caregiver
Interdisciplinary
Intervention
Occupational Therapy
Psychoeducational
Psychology
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Caring for an older dependent adult with cognitive impairment can have negative consequences for the family caregiver. Interdisciplinary interventions are necessary to address their needs jointly and comprehensively. While attempts have been made to improve their situation from different disciplines in isolation, a collaborative approach is required to ensure the best possible outcome.

Methods: A parallel, randomized, controlled clinical trial with two arms will be conducted at the Occupational Therapy Teaching and Care Unit (UDATO) and the Municipal Psychosocial Support Unit for the Elderly (UMAPS), both of which belong to the University of Salamanca and are in agreement with the City Council of Salamanca, Spain. The trial will also be conducted at the University Care Centre of Salamanca (CAUSA). People aged 60 years or older will be recruited as family caregivers of dependent older adults with cognitive impairment in a chronic situation. Participants will be divided into two groups: the intervention group (IG) will carry out an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy, and the control group (CG) will carry out a controlled follow-up. Participants will complete 12 sessions over a period of 3 months, followed by three monthly reinforcement sessions after the intervention. At the beginning and end of the intervention, participants will be assessed and socio-demographic data will be collected along with the following scales: the Spanish version of the Caregiver Burden Interview (CBI), the Spanish version of the Center for Epidemiologic Studies-Depression Scale (CES-D), the Psychosocial Support Questionnaire adaptation (PSQ), the General Health Questionnaire (GHQ), the World Health Organization Quality of Life Assessment - AGE (WHOQOL-AGE) and the Bayer-Activities of Daily Living Scale (B-ADL).

Discussion: The objective of this study is to enhance conventional clinical practice for family caregivers of dependent older adults. This will be achieved through an interdisciplinary psychoeducational intervention that aims to reduce overload and depressive symptomatology, increase social support, improve health and perceived quality of life, and enhance understanding of the syndrome/illness. The intervention will also focus on managing difficult situations associated with day-to-day caregiving, managing emotions and associated erroneous beliefs, and promoting self-care. Additionally, the study aims to improve the functionality of the cared-for person.


Eligibility criteria: Inclusion Criteria:

* Be the primary family caregiver of a person with cognitive impairment (Mini Mental State Examination (MMSE) \< 24 points in a situation of moderate or severe dependency (Barthel) ≤ 55
* Be aged 60 years or older; have been the primary family caregiver for one year or more
* Voluntarily sign the consent form to participate and complete the initial assessment.

Exclusion Criteria:

* Lack of literacy or significant deficits in language comprehension and being a formal carer -
* Receiving financial remuneration for caring for the sick person.

Primary outcomes:
measure: Mini Mental State Examination (MMSE)
timeFrame: Baseline; "3 months follow up"; "up to 24 weeks"
measure: Barthel Index
timeFrame: Baseline; "3 months follow up"; "up to 24 weeks"
measure: Caregiver Burden Interview
timeFrame: Baseline; "3 months follow up"; "up to 24 weeks"
Secondary outcomes:
measure: Centre for Epidemiological Studies Depression Scale
timeFrame: Baseline; "3 months follow up"; "up to 24 weeks"
measure: Adaptation of the Psychosocial Support Questionnaire
timeFrame: Baseline; "3 months follow up"; "up to 24 weeks"
measure: General Health Questionnaire
timeFrame: Baseline; "3 months follow up"; "up to 24 weeks"
measure: World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE)
timeFrame: Baseline; "3 months follow up"; "up to 24 weeks"
measure: The Bayer-Activities of Daily Living Scale (B-ADL)
timeFrame: Baseline; "3 months follow up"; "up to 24 weeks"
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Eduardo Jose Fernandez Rodriguez
state: Castilla Y Leon
Study officials:
References: