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CompletedNCT05359978Updated May 16, 2022

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

An interventional study of To with significance activities in Dementia, sponsored by Universidad de Burgos. Completed at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-05-16.

Sponsored by Universidad de Burgos · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jan 2019, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Dementia

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Keywords

  • Occupational Therapy
  • Dementia
  • Significance activities
  • No-pharmacological treatment
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 240 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Universidad de Burgos is the lead sponsor of 24 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    cards

    participants received 2 days at week during 30 minutes

    Behavioral: To with significance activities

  • Experimental
    significance activities

    participants received 2 days a week during 30 minutes

    Behavioral: To with significance activities

Interventions

  • BehavioralTo with significance activities

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 days

  2. 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.

    Time frame: 2 days

  3. 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

    Time frame: 2 days

  4. 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

    Time frame: 2 days

  5. 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

    Time frame: 2 days

07

Study locations

1 site
  • Olalla Saiz Vazquez
    Burgos, 09003, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05359978
Lead sponsor
Universidad de Burgos
Responsible party
OLALLA SAIZ VAZQUEZ (Graduado en Terapia Ocupacional, Universidad de Burgos) — Principal investigator
First posted
May 4, 2022
Start date
Jan 1, 2019
Primary completion
Mar 20, 2022
Completion
Apr 20, 2022
Last update
May 16, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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