DementiaNCT05359978
Treatment in Occupational Therapy With Significant Activities to Improve Quality of Life
A study testing To with significance activities in people with Dementia, run by Universidad de Burgos at 1 site in Spain.
Trial summary
We followed a pretest-posttest non-equivalent control group experimental design study comparing two cohorts of patient with different types of dementia. Approximately 250 patients will be screened to achieve 240 participants, divided in two cohorts (120 each), furthermore each cohorts was divided in other two groups… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- To with significance activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 20 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- a diagnosis of primary dementia (DSM V)
- a MMSE score ≤ 24
- a NPI global score ≥ 32/144
- a treatment with significance activities in Occupational Therapy
- live in a nursing home
Who cannot join
- presence of uncontrolled medical disease potentially contributing to the cognitive decline and BPSD
- concomitant psychiatric disorders or chronic alcoholism
- concomitant diseases severe enough to reduce life expectancy < 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occupational Therapy Intervention for Alzheimer's Disease Patients. An International Comparison in Spain and Italy.
We followed a pretest-posttest non-equivalent control group experimental design study comparing two cohorts of patient with different types of dementia.
Approximately 250 patients will be screened to achieve 240 participants, divided in two cohorts (120 each), furthermore each cohorts was divided in other two groups (experimental group (60 each) and control group (60 each) the first one followed up by private centres in Spain endowed with Occupational Therapy and the second by public centres in the region of Modena.
Read the detailed description
The course of dementia goes through different stages and during the moderate and advanced stages cognitive decline and functional deterioration are frequently accompanied by the so-called behavioural and psychological symptoms of dementia (BPSD), that put severe stress on the persons with dementia (PwD), on their families and on the health system. Worldwide consensus guidelines recommend non-pharmacological approaches to be first line.
The occupational therapist studies human activity as a therapeutic resource to prevent and treat physical and/or psychosocial difficulties, in order to improve the person's quality of life.
Subjects were not randomly assigned to different treatment groups (control group and experimental group); instead, consecutive sampling was chosen by assigning subjects based on an odd-and-even-numbered technique (odd subjects were assigned to the control group and even subjects to the experimental group). Both groups presented the same pathological, cultural, and sexual characteristics, and belonged to the same age group.
- Conditions
- Dementia
- Being tested
- To with significance activities
- Keywords
- Occupational Therapy, Dementia, Significance activities, No-pharmacological treatment
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To with significance activitiesBehavioural
activities with purpose with people who are diagnosed of dementia 2 days at week during 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| cards | Experimental | participants received 2 days at week during 30 minutes Receives: Behavioral: To with significance activities |
| significance activities | Experimental | participants received 2 days a week during 30 minutes Receives: Behavioral: To with significance activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinetti
- The Tinetti test has been recommended and widely used in the elderly to assess mobility, balance and gait, and predict falls. Different versions can be found. A systematic literature search identified 37 publications on the Tinetti test and falls.
Measured: 2 days
CDR
- The Clinical Dementia Rating (CDR) has demonstrated high validity and reliability for this purpose, but it requires a considerable amount of data to be collected both from the patient and from an informant.
Measured: 2 days
MMSE
- The MMSE fulfilled its original goal of providing a brief screening test that quantitatively assesses the severity of cognitive impairment and documents cognitive changes occurring over time
Measured: 2 days
NPI
- The NPI-Q Spanish version offers the possibility to use a reliable and brief instrument that can be used as a screening in the evaluation of neuropsychiatric symptoms in dementia and associated caregiver distress
Measured: 2 days
Barthel
- Evidence suggests that (Barthel Index) BI is a valid measure of activities of daily living; sensitivity to change is limited at extremes of disability (floor and ceiling effects), and reliability of standard BI assessment is acceptable
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Jan 2019
- Primary completion20 Mar 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- It's a pretest-posttest non-equivalent control group experimental design study comparing two cohorts of patient with different types of dementia
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OLALLA SAIZ VAZQUEZ, Universidad de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359978
- Sponsor's protocol ID
- UBurgos2
- Status last verified
- May 2022
- First submitted
- 20 Apr 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy Intervention for Alzheimer's Disease Patients. An International Comparison in Spain and Italy.
- ClinicalTrials.gov ID
- NCT05359978
- Acronym / sponsor ID
- UBurgos2
- Conditions
- Dementia
- Keywords
- Occupational Therapy, Dementia, Significance activities, No-pharmacological treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 4 May 2022 (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.
We followed a pretest-posttest non-equivalent control group experimental design study comparing two cohorts of patient with different types of dementia.
Approximately 250 patients will be screened to achieve 240 participants, divided in two cohorts (120 each), furthermore each cohorts was divided in other two groups (experimental group (60 each) and control group (60 each) the first one followed up by private centres in Spain endowed with Occupational Therapy and the second by public centres in the region of Modena.
Detailed description
The course of dementia goes through different stages and during the moderate and advanced stages cognitive decline and functional deterioration are frequently accompanied by the so-called behavioural and psychological symptoms of dementia (BPSD), that put severe stress on the persons with dementia (PwD), on their families and on the health system. Worldwide consensus guidelines recommend non-pharmacological approaches to be first line.
The occupational therapist studies human activity as a therapeutic resource to prevent and treat physical and/or psychosocial difficulties, in order to improve the person's quality of life.
Subjects were not randomly assigned to different treatment groups (control group and experimental group); instead, consecutive sampling was chosen by assigning subjects based on an odd-and-even-numbered technique (odd subjects were assigned to the control group and even subjects to the experimental group). Both groups presented the same pathological, cultural, and sexual characteristics, and belonged to the same age group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It's a pretest-posttest non-equivalent control group experimental design study comparing two cohorts of patient with different types of dementia
| Arm | Type | Receives |
|---|---|---|
| cards | Experimental | Behavioral: To with significance activitiesparticipants received 2 days at week during 30 minutes |
| significance activities | Experimental | Behavioral: To with significance activitiesparticipants received 2 days a week during 30 minutes |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- a diagnosis of primary dementia (DSM V)
- a MMSE score ≤ 24
- a NPI global score ≥ 32/144
- a treatment with significance activities in Occupational Therapy
- live in a nursing home
Key exclusion criteria (3 listed)
- presence of uncontrolled medical disease potentially contributing to the cognitive decline and BPSD
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 |
|---|---|---|
| To with significance activitiesactivities with purpose with people who are diagnosed of dementia 2 days at week during 30 minutes | Behavioural | cards, significance activities |
Primary outcome
Tinetti
Time frame: 2 days
- The Tinetti test has been recommended and widely used in the elderly to assess mobility, balance and gait, and predict falls. Different versions can be found. A systematic literature search identified 37 publications on the Tinetti test and falls.
CDR
Time frame: 2 days
- The Clinical Dementia Rating (CDR) has demonstrated high validity and reliability for this purpose, but it requires a considerable amount of data to be collected both from the patient and from an informant.
MMSE
Time frame: 2 days
- The MMSE fulfilled its original goal of providing a brief screening test that quantitatively assesses the severity of cognitive impairment and documents cognitive changes occurring over time
NPI
Time frame: 2 days
- The NPI-Q Spanish version offers the possibility to use a reliable and brief instrument that can be used as a screening in the evaluation of neuropsychiatric symptoms in dementia and associated caregiver distress
Barthel
Time frame: 2 days
- Evidence suggests that (Barthel Index) BI is a valid measure of activities of daily living; sensitivity to change is limited at extremes of disability (floor and ceiling effects), and reliability of standard BI assessment is acceptable
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 16 May 2022.
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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 To with significance activities in people with Dementia, 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 5 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 16 May 2022. 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?
Tinetti (time frame: 2 days). The study lists 5 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 16 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.