ClinicalTrials.Veeva

Menu

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

U

Universidad de Burgos

Status

Completed

Conditions

Dementia

Treatments

Behavioral: To with significance activities

Study type

Interventional

Funder types

Other

Identifiers

NCT05359978
UBurgos2

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

240 participants in 2 patient groups

cards
Experimental group
Description:
participants received 2 days at week during 30 minutes
Treatment:
Behavioral: To with significance activities
significance activities
Experimental group
Description:
participants received 2 days a week during 30 minutes
Treatment:
Behavioral: To with significance activities

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems