Clinical trial NCT05359978: Treatment in Occupational Therapy With Significant Activities to Improve Quality of Life
Official title: Occupational Therapy Intervention for Alzheimer's Disease Patients. An International Comparison in Spain and Italy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Occupational Therapy
Dementia
Significance activities
No-pharmacological treatment
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tinetti
timeFrame: 2 days
measure: CDR
timeFrame: 2 days
measure: MMSE
timeFrame: 2 days
measure: NPI
timeFrame: 2 days
measure: Barthel
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Olalla Saiz Vazquez
Study officials:
References: