Terminal IllnessNCT06628856
Quality of Life of the Piloted Individuals and a Cost-efficiency Analysis
A study testing Quality of life in people with Terminal Illness, run by Universidad de Burgos at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Terminal Illness
- What is being tested?
- Quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2024to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Terminal Illness
- Being tested
- Quality of life
- Keywords
- Person-centred care, meaningful activities, direct care professional, occupational therapist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of lifeOther
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 group | Role | What they receive |
|---|---|---|
| HOSPITAL CHILE | Experimental | 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) Receives: Other: Quality of life |
| HOSPITAL SPAIN | Experimental | 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) Receives: Other: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 MONTHS
Multilevel analysis
daily records: Multilevel analyses will be performed by applying Mix Models with maximum likelihood (ML) estimation.
Measured: 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).
Measured: 5 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start7 Jan 2024
- Primary completion7 Feb 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terminal IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628856
- Sponsor's protocol ID
- ACP 2/2023
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Ante and Interim Evaluation of the Quality of Life of the Piloted Persons, and Cost-efficiency Analysis
- ClinicalTrials.gov ID
- NCT06628856
- Acronym / sponsor ID
- ACP 2/2023
- Conditions
- Terminal Illness
- Keywords
- Person-centred care, meaningful activities, direct care professional, occupational therapist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOSPITAL CHILE | Experimental | Other: Quality of lifeThe 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) |
| HOSPITAL SPAIN | Experimental | Other: Quality of lifeThe 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) |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of lifeThe 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. | Other | HOSPITAL CHILE, HOSPITAL SPAIN |
Primary outcome
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.
Multilevel analysis
Time frame: 5 MONTHS
daily records: Multilevel analyses will be performed by applying Mix Models with maximum likelihood (ML) estimation.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life in people with Terminal Illness, run by Universidad de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative analysis (time frame: 5 MONTHS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.