Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults

Not Applicable

Not yet recruiting

• Conditions: Dependent Older People; Family Caregiver; Interdisciplinary; Intervention; Psychoeducational; Occupational Therapy; Psychology

• Registration Number: NCT06326151
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-16
• Last Update Submitted: 2024-03-16
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Study Start: 2024-09-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mini Mental State Examination (MMSE)	Baseline; "3 months follow up"; "up to 24 weeks"	temporal and spatial orientation, fixation, attention and arithmetic, memory, nomination, repetition, comprehension, reading, writing and drawing.
Barthel Index	Baseline; "3 months follow up"; "up to 24 weeks"	degree of dependency in activities of daily living
Caregiver Burden Interview	Baseline; "3 months follow up"; "up to 24 weeks"	perceived overload

Secondary Outcome Measures

Name	Time	Method
World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE)	Baseline; "3 months follow up"; "up to 24 weeks"	Quality of Life
The Bayer-Activities of Daily Living Scale (B-ADL)	Baseline; "3 months follow up"; "up to 24 weeks"	functional disabilities in elderly patients with mild to moderate dementia or cognitive impairment
Adaptation of the Psychosocial Support Questionnaire	Baseline; "3 months follow up"; "up to 24 weeks"	perceived psychosocial support
General Health Questionnaire	Baseline; "3 months follow up"; "up to 24 weeks"	perceived health
Centre for Epidemiological Studies Depression Scale	Baseline; "3 months follow up"; "up to 24 weeks"	depressive symptoms

Trial Locations

Locations (1)

Eduardo Jose Fernandez Rodriguez; 🇪🇸 Salamanca, Castilla Y Leon, Spain