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

NCT ID: NCT05359978

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-04-20

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

cards

participants received 2 days at week during 30 minutes

Group Type: EXPERIMENTAL

To with significance activities

Intervention Type: BEHAVIORAL

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

significance activities

participants received 2 days a week during 30 minutes

Group Type: EXPERIMENTAL

To with significance activities

Intervention Type: BEHAVIORAL

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

Interventions

To with significance activities

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Burgos

OTHER

Sponsor Role: lead

Responsible Party

OLALLA SAIZ VAZQUEZ

Graduado en Terapia Ocupacional

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Olalla Saiz Vazquez

Burgos, , Spain

Countries

Spain

Other Identifiers

UBurgos2

Identifier Type: -

Identifier Source: org_study_id