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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05359978
• Other study ID #: UBurgos2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 20, 2022

Study information

• Verified date: May 2022
• Source: Universidad de Burgos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 20, 2022
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• To with significance activities
activities with purpose with people who are diagnosed of dementia 2 days at week during 30 minutes

Locations

Country	Name	City	State
Spain	Olalla Saiz Vazquez	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Burgos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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