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

NCT05359978 | Completed DMC

• 1 other identifier: UBurgos2
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

  2 days

• 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.

  2 days

• 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

  2 days

• 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

  2 days

• 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

  2 days

Study Arms (2)

cards

EXPERIMENTAL

participants received 2 days at week during 30 minutes

Behavioral: To with significance activities

significance activities

EXPERIMENTAL

participants received 2 days a week during 30 minutes

Behavioral: To with significance activities

Interventions

To with significance activities BEHAVIORAL

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

cards; significance activities

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Burgos: lead

Study Sites (1)

Olalla Saiz Vazquez

Burgos, 09003, Spain

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduado en Terapia Ocupacional

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

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 4, 2022
• Study Start: January 1, 2019
• Primary Completion: March 20, 2022
• Study Completion: April 20, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Locations

ES (1)