Old Age; DementiaIO/20240924NCT06623864
Significant Activities in the Integrated Person-centered Care Model
A study testing meaningful activities and other activities in people with Old Age; Dementia and Old Age; Debility, 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 60 years and older, men only
- Conditions the study is for
- Old Age; Dementia, Old Age; Debility
- What is being tested?
- meaningful activities and other activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 24 Sep 2024to 20 Jan 2025
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, 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.
Spain1 site, 1 recruiting
- Recruiting
Olalla Saiz Vazquez
Burgos, Burgos, 09003
Olalla Saiz Vazquez, +34625685700, osaiz@ubu.es
About this study
Official title: Significant Activities in the Implementation of the Integrated Person-centered Care Model: Intervention Protocol
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: To improve Person-Centred Care in a geriatric centre, through the use of meaningful activities and to identify the role of the occupational therapist and direct care professional in the development of these activities.
Methods: A descriptive cross-sectional quasi-experimental pre-post single-group design is proposed. A total of 10 participants. The methodology used will be mixed. The data collection techniques and tools will be the PDC evaluation instrument pre and post intervention and a survey at the end of the project.
- Conditions
- Old Age; Dementia, Old Age; Debility
- Being tested
- meaningful activities, other activities
- Medical subject headings
- Alzheimer Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meaningful activitiesOther
The intervention proposal will be developed in a module with 27 elderly people, all of them men, with moderate dependence and older, with an average age of 84 years. All of them have multiple medical pathologies with the need for continuous nursing care.
other activitiesOther
The intervention proposal will be developed in a module with 27 elderly people, all of them men, with moderate dependence and older, with an average age of 84 years. All of them have multiple medical pathologies with the need for continuous nursing care.
| Study group | Role | What they receive |
|---|---|---|
| single group | Experimental | The intervention proposal will be developed in a module with 10 elderly people, all of them men, with moderate dependence and older, with an average age of 84 years. All of them have multiple medical pathologies with the need for continuous nursing care. Receives: Other: meaningful activities |
| CONTROL GROUP | Experimental | The intervention proposal will be developed in a module with 10 elderly people, all of them men, with moderate dependence and older, with an average age of 84 years. All of them have multiple medical pathologies with the need for continuous nursing care. Receives: Other: other activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kruskal-Wallis test
To compare the medians of the groups
Measured: 3 months
Spearman's correlation coefficient
This measure allows us to determine the strength and direction of the association between the variables
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start24 Sep 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Old Age; DementiaStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623864
- Sponsor's protocol ID
- IO/20240924
- Acronym
- IO/20240924
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Although each participant will provide their name and email address to register for the study, their data and survey results will be completely anonymous and linked to a participant code. On each measurement occasion, participants will be emailed a link to the survey and, when clicked, will be taken to the google-forms web platform that will host the surveys. The web surveys will not ask for any information that can be used to identify a specific participant, and google-forms will not record any metadata.
Publications
McCormack, B., & McCance, T. (2017). Person-Centred Practice in Nursing and Health Care: Theory and Practice. Wiley-Blackwell.
World Health Organization. (2016). Framework on Integrated, People-Centred Health Services. WHO.
Gittell, J. H., & Vidal, M. (2018). Relational Coordination: Guidelines for Theory and Practice. Oxford University Press.
Edvardsson, D., & Innes, A. (2017). Measuring Person-Centred Care: A Review of Tools and Methodologies. Journal of Nursing Scholarship, 49(2), 223-235. https://doi.org/10.1111/jnu.12276
Dewing, J. (2008). Person-Centred Dementia Care: A Vision to Be Realised. Journal of Nursing Management, 16(3), 261-268. https://doi.org/10.1111/j.1365-2834.2007.00848.x
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significant Activities in the Implementation of the Integrated Person-centered Care Model: Intervention Protocol
- ClinicalTrials.gov ID
- NCT06623864
- Acronym / sponsor ID
- IO/20240924 / IO/20240924
- Conditions
- Old Age; Dementia, Old Age; Debility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 2 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: To improve Person-Centred Care in a geriatric centre, through the use of meaningful activities and to identify the role of the occupational therapist and direct care professional in the development of these activities.
Methods: A descriptive cross-sectional quasi-experimental pre-post single-group design is proposed. A total of 10 participants. The methodology used will be mixed. The data collection techniques and tools will be the PDC evaluation instrument pre and post intervention and a survey at the end of the project.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single group | Experimental | Other: meaningful activitiesThe intervention proposal will be developed in a module with 10 elderly people, all of them men, with moderate dependence and older, with an average age of 84 years. All of them have multiple medical pathologies with the need for continuous nursing care. |
| CONTROL GROUP | Experimental | Other: other activitiesThe intervention proposal will be developed in a module with 10 elderly people, all of them men, with moderate dependence and older, with an average age of 84 years. All of them have multiple medical pathologies with the need for continuous nursing care. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, 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 |
|---|---|---|
| meaningful activitiesThe intervention proposal will be developed in a module with 27 elderly people, all of them men, with moderate dependence and older, with an average age of 84 years. All of them have multiple medical pathologies with the need for continuous nursing care. | Other | single group |
| other activitiesThe intervention proposal will be developed in a module with 27 elderly people, all of them men, with moderate dependence and older, with an average age of 84 years. All of them have multiple medical pathologies with the need for continuous nursing care. | Other | CONTROL GROUP |
Primary outcome
Kruskal-Wallis test
Time frame: 3 months
To compare the medians of the groups
Spearman's correlation coefficient
Time frame: 3 months
This measure allows us to determine the strength and direction of the association between the variables
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- BackgroundMcCormack, B., & McCance, T. (2017). Person-Centred Practice in Nursing and Health Care: Theory and Practice. Wiley-Blackwell.
- BackgroundWorld Health Organization. (2016). Framework on Integrated, People-Centred Health Services. WHO.
- BackgroundGittell, J. H., & Vidal, M. (2018). Relational Coordination: Guidelines for Theory and Practice. Oxford University Press.
- BackgroundEdvardsson, D., & Innes, A. (2017). Measuring Person-Centred Care: A Review of Tools and Methodologies. Journal of Nursing Scholarship, 49(2), 223-235. https://doi.org/10.1111/jnu.12276
- BackgroundDewing, J. (2008). Person-Centred Dementia Care: A Vision to Be Realised. Journal of Nursing Management, 16(3), 261-268. https://doi.org/10.1111/j.1365-2834.2007.00848.x
- Individual participant dataSharing planned: No. Although each participant will provide their name and email address to register for the study, their data and survey results will be completely anonymous and linked to a participant code. On each measurement occasion, participants will be emailed a link to the survey and, when clicked, will be taken to the google-forms web platform that will host the surveys. The web surveys will not ask for any information that can be used to identify a specific participant, and google-forms will not record any metadata.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meaningful activities and other activities in people with Old Age; Dementia and Old Age; Debility, 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: status not confirmed, as of the sponsor's last update on 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kruskal-Wallis test (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06623864, which also lists 5 linked publications.
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 2 Oct 2024.