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Completed

NCT Number: NCT05359978

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Olalla Saiz Vazquez

Burgos, 09003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

To with significance activities

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Universidad de Burgos

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 4, 2022
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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