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Treatment in Occupational Therapy With Significant Activities to Improve Quality of Life

Occupational Therapy Intervention for Alzheimer's Disease Patients. An International Comparison in Spain and Italy.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05359978
Enrollment
240
Registered
2022-05-04
Start date
2019-01-01
Completion date
2022-04-20
Last updated
2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Occupational Therapy, Dementia, Significance activities, No-pharmacological treatment

Brief 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 (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.

Interventions

BEHAVIORALTo with significance activities

activities with purpose with people who are diagnosed of dementia 2 days at week during 30 minutes

Sponsors

Universidad de Burgos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

It's a pretest-posttest non-equivalent control group experimental design study comparing two cohorts of patient with different types of dementia

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Tinetti2 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.
CDR2 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.
MMSE2 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
NPI2 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
Barthel2 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026