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NCT Number: NCT06628856

Quality of Life of the Piloted Individuals and a 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.

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Key information

Conditions

Terminal Illness

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Olalla Saiz Vazquez

Burgos, 09003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of life

Other

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.

Primary outcomes

  1. Qualitative analysis

    Time frame: 5 MONTHS

    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.

  2. Multilevel analysis

    Time frame: 5 MONTHS

    daily records: Multilevel analyses will be performed by applying Mix Models with maximum likelihood (ML) estimation.

  3. Student's t-tests

    Time frame: 5 MONTHS

    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).

Sponsors and collaborators

Lead sponsor

Universidad de Burgos

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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