Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults

Intervention Clinical Trial

Official title:

Study for a Randomised Controlled Trial: Effect of an Interdisciplinary Psycho-educational Intervention Programme on Caregivers of Dependent Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326151
• Other study ID #: UMAPS-UDATO
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Family Caregiver
• Intervention
• Occupational Therapy
• Psychology

Intervention

Behavioral:
• Interdisciplinary Psychoeducational Programme
This intervention is based on the principle of complementing and integrating both disciplines in order to meet the psychological needs of family carers and to train them in knowledge and strategies aimed at the correct performance of activities of daily living in order to promote the maximum autonomy and functionality of dependent people with cognitive impairment, and that this favours discharge, self-care, improvement of the affective state and quality of life of family carers.
• Health Education Programme
Upon discharge from the hospital, at the end of the baseline assessment, caregivers will receive instructions and recommendations for maintaining an active and healthy lifestyle. This will be done by encouraging self-care and good practices in caring for their dependent family member, as part of a health education programme. The benefits of an active lifestyle and general guidelines are emphasized.

Locations

Country	Name	City	State
Spain	Eduardo Jose Fernandez Rodriguez	Salamanca	Castilla Y Leon

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini Mental State Examination (MMSE)	temporal and spatial orientation, fixation, attention and arithmetic, memory, nomination, repetition, comprehension, reading, writing and drawing.	Baseline; "3 months follow up"; "up to 24 weeks"
Primary	Barthel Index	degree of dependency in activities of daily living	Baseline; "3 months follow up"; "up to 24 weeks"
Primary	Caregiver Burden Interview	perceived overload	Baseline; "3 months follow up"; "up to 24 weeks"
Secondary	Centre for Epidemiological Studies Depression Scale	depressive symptoms	Baseline; "3 months follow up"; "up to 24 weeks"
Secondary	Adaptation of the Psychosocial Support Questionnaire	perceived psychosocial support	Baseline; "3 months follow up"; "up to 24 weeks"
Secondary	General Health Questionnaire	perceived health	Baseline; "3 months follow up"; "up to 24 weeks"
Secondary	World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE)	Quality of Life	Baseline; "3 months follow up"; "up to 24 weeks"
Secondary	The Bayer-Activities of Daily Living Scale (B-ADL)	functional disabilities in elderly patients with mild to moderate dementia or cognitive impairment	Baseline; "3 months follow up"; "up to 24 weeks"