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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
To with significance activities
Sponsored by
Universidad de Burgos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia focused on measuring Occupational Therapy, Dementia, Significance activities, No-pharmacological treatment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Olalla Saiz Vazquez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

cards

significance activities

Arm Description

participants received 2 days at week during 30 minutes

participants received 2 days a week during 30 minutes

Outcomes

Primary Outcome Measures

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.
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.
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
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
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

Secondary Outcome Measures

Full Information

First Posted
April 20, 2022
Last Updated
May 9, 2022
Sponsor
Universidad de Burgos
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1. Study Identification

Unique Protocol Identification Number
NCT05359978
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 20, 2022 (Actual)
Study Completion Date
April 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Burgos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Occupational Therapy, Dementia, Significance activities, No-pharmacological treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
It's a pretest-posttest non-equivalent control group experimental design study comparing two cohorts of patient with different types of dementia
Masking
Participant
Masking Description
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
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cards
Arm Type
Experimental
Arm Description
participants received 2 days at week during 30 minutes
Arm Title
significance activities
Arm Type
Experimental
Arm Description
participants received 2 days a week during 30 minutes
Intervention Type
Behavioral
Intervention Name(s)
To with significance activities
Intervention Description
activities with purpose with people who are diagnosed of dementia 2 days at week during 30 minutes
Primary Outcome Measure Information:
Title
Tinetti
Description
- 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
Title
CDR
Description
- 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
Title
MMSE
Description
- 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
Title
NPI
Description
- 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
Title
Barthel
Description
- 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Olalla Saiz Vazquez
City
Burgos
ZIP/Postal Code
09003
Country
Spain

12. IPD Sharing Statement

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

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