Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia

NCT06320093 | Completed

• 1 other identifier: INRCA_002_2024
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 3

Brief Summary

The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia.

Conditions

Dementia; Older People

Keywords

dementia; older people; music; caregiver

Outcome Measures

Primary Outcomes (3)

• Change in mental wellbeing of patients with dementia

  The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks): All of the time = 5; Most of the time = 4; More than half of the time = 3; Less than half of the time = 2 Some of the time = 1; At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.

  baseline, 12 and 14 weeks later

• Change in cognitive status of patients with dementia

  The cognitive status has been evaluated by the Montreal Cognitive Assessment (MOCA) test. MOCA is an assessment tool used globally to detect early onset of dementia among people of old age. The tool is a one-page 30-point test that the physician can administer to check the memory, language, recall, and other markers of cognitive acuity of a patient. Normal cognition: 26-30 points; Mild Cognitive Impairment: 18-25 points; Moderate Cognitive Impairment: 10-17 points; Severe Cognitive Impairment: under 10 points.

  baseline, 12 and 14 weeks later

• Change in stress of health care providers

  The Burnout Assessment Tool (BAT) is a self-assessment questionnaire that measures parameters associated with Burnout. All items are expressed as statements with five frequency-based response categories (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). The total burnout score is calculated as a mean of all 23 items, and a high score is indicative of high levels of burnout.

  baseline, 12 and 14 weeks later

Study Arms (1)

Sound intervention

EXPERIMENTAL

the SOUND intervention is a new and innovative method of applying musical activities in a circle consisting of elderly people with mild-to-moderate dementia, caregivers, family caregivers and young people.

Other: SOUND Intervention

Interventions

SOUND Intervention OTHER

The intervention involved active (vocal and rhythmic production) and passive (listening to musical pieces) musical activities accompanied by motor coordination exercises. It consisted of 12 meetings (2 per week for 6 weeks) of 45 minutes each.

Sound intervention

Eligibility Criteria

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

You may qualify if:

• mild to moderate dementia
• no severe hearing and visual impairment or motor problems

You may not qualify if:

• no formal caregiver
• no informal caregiver

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• European Union: collaborator

Study Sites (3)

INRCA Hospital

Ancona, 60127, Italy

Location

Sons do Estamine Associacao

Trofa, Portugal

Location

Associatia Habilitas

Bucharest, Romania

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: October 3, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1); IT (1); PT (1)