Quality of Life of the Piloted Individuals and a Cost-efficiency Analysis

Ex Ante and Interim Evaluation of the Quality of Life of the Piloted Persons, and Cost-efficiency Analysis

The increasing life expectancy and global aging population necessitate changes in long-term gerontological services based on Person-Centred Care approaches. This study aims to improve Person-Centred Care in geriatric centers through meaningful activities and the role of occupational therapists and direct care professionals in developing these activities. A descriptive cross-sectional quasi-experimental design was proposed, with 10 participants.

Study Overview

• Status: Completed
• Conditions: Terminal Illness
• Intervention / Treatment: Other: Quality of life

Detailed Description

Background: Increasing life expectancy means that the ageing of populations globally is on the rise. It is therefore important to promote changes in long-term gerontological services based on Person-Centred Care approaches, in which meaningful occupation serves as a basis and is supported by appropriate professional support, such as the occupational therapist and the direct care professional.

Objective: The study aims to analyze the needs, quality of life, and coping strategies of terminally ill patients over five months, as well as burnout and dehumanization among caregivers and healthcare staff.

Methods: This study examines factors influencing the quality of life (QOL) of terminally ill patients and the burnout and dehumanization of caregivers and health professionals using a mixed methodology. The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Burgos, Spain, 09003
    • Olalla Saiz Vazquez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• That the direct care worker has a degree as a nursing assistant, dependency care technician, geroculturist or certificate of professionalism.
• The worker must speak and understand Spanish.
• The residence must offer service during the day, in the morning or afternoon shift.
• Workers must have been with the department for more than 4 months.

Exclusion Criteria:

• Workers who work night shift only.
• Workers on rotating shifts in all departments of the residence.
• Workers absent at the time of the study due to temporary leave, vacations or other causes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HOSPITAL CHILE; The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being. (N=286)	Other: Quality of life; The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being.
Experimental: HOSPITAL SPAIN; The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being. (N=286)	Other: Quality of life; The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative analysis	structured interviews: The coding system for the qualitative information will be carried out using the Atlas-Ti content analysis program. Atlas-Ti allows exporting a matrix to SPSS format, as a quantitative data matrix composed of the set of ideas, identified by the code of each interview, the idea number and its corresponding code for affected person and family member. In this way, the frequencies of the different categories can be analyzed.	5 MONTHS
Multilevel analysis	daily records: Multilevel analyses will be performed by applying Mix Models with maximum likelihood (ML) estimation.	5 MONTHS
Student's t-tests	telematic records: Student's t-tests for independent samples and ANOVAs/ANCOVAs will be applied to analyze differences in the study variables (needs, QOL, coping strategies) according to sociodemographic (sex, age, educational level) and clinical variables (type of disease, type of treatment or dependency status).	5 MONTHS

Collaborators and Investigators

• Sponsor: Universidad de Burgos

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2024
• Primary Completion (Actual): February 7, 2024
• Study Completion (Actual): March 7, 2024

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Person-centred care; meaningful activities; direct care professional; occupational therapist
• Other Study ID Numbers: ACP 2/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No