Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Occupational Therapy; Intervention; Family Caregiver; Psychology; Dependent Older People; Interdisciplinary; Psychoeducational
• Intervention / Treatment: Behavioral: Health Education Programme; Behavioral: Interdisciplinary Psychoeducational Programme

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Castilla Y Leon
    • Salamanca, Castilla Y Leon, Spain, 37002
      • Eduardo Jose Fernandez Rodriguez
      • Contact: Eduardo PhD Fernandez, PhD; Phone Number: 923294500; Email: edujfr@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Health Education Programme; Why: 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. What (materials): Instructions and recommendations for a health education programme. What (procedures): Participants will receive instructions and recommendations on how to maintain an active and healthy lifestyle, promoting self-care and good practices in caring for their dependent family member. How: The caregiver will receive the material individually at the time of referral, before being discharged from the hospital. When and for how long: The intervention consists of a single session and details of the time and duration will be provided to participants.	Behavioral: 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.
Experimental: Interdisciplinary Psychoeducational Programme; Why: The programme is based on an interdisciplinary psychoeducational intervention from the fields of occupational therapy and psychology. What (materials): projector, computer, screen, presentation of content, stationery, chairs, tables and self-recording of home tasks. What (procedures): Patients assigned to the experimental group will follow an interdisciplinary psychoeducational programme structured and supervised at the University of Salamanca, consisting of a health education programme combined with an interdisciplinary psychoeducational programme from the perspective of psychology and occupational therapy. Who will carry out the interventions: modules: (I) understanding the syndrome or disease and managing difficult everyday caring situations or behaviours, (II) emotions and misconceptions about caring, and (III) self-care (Table 1). When and for how long: Each participant will receive 4 sessions per month for 3 months, for a total of 12 sessions.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"
Barthel Index	degree of dependency in activities of daily living	Baseline; "3 months follow up"; "up to 24 weeks"
Caregiver Burden Interview	perceived overload	Baseline; "3 months follow up"; "up to 24 weeks"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Centre for Epidemiological Studies Depression Scale	depressive symptoms	Baseline; "3 months follow up"; "up to 24 weeks"
Adaptation of the Psychosocial Support Questionnaire	perceived psychosocial support	Baseline; "3 months follow up"; "up to 24 weeks"
General Health Questionnaire	perceived health	Baseline; "3 months follow up"; "up to 24 weeks"
World Health Organization Assessment of Quality of Life - AGE (WHOQOL-AGE)	Quality of Life	Baseline; "3 months follow up"; "up to 24 weeks"
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"

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: UMAPS-UDATO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: They will be made available to researchers in the document repository "GREDOS" of the University of Salamanca, Spain.
• IPD Sharing Time Frame: Data will be available at the end of the study.
• IPD Sharing Access Criteria: Open access for researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No