Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-11
Brief Title:
Interdisciplinary Psychoeducational Intervention Programme for Caregivers of Dependent Older Adults
Sponsor:
University of Salamanca
Organization:
University of Salamanca
Study Overview
Official Title:
Study for a Randomised Controlled Trial Effect of an Interdisciplinary Psycho-educational Intervention Programme on Caregivers of Dependent Older Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 syndromeillness 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
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 syndromeillness 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None