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

Dementia Clinical Trial

— SOUND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06320093
• Other study ID #: INRCA_002_2024
• Status: Completed
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: March 2024
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study aims to develop an innovative therapeutic intervention (SOUND intervention) based on the use of music to improve behavior, mood, well-being, and maintain cognitive function in older people with dementia.

The study will investigate the effects of the SOUND intervention on 45 professionals in the field of dementia, 45 elderly people with dementia, and 5 family caregivers by monitoring quantitative outcome variables that will be measured through psychometric and qualitative scales interpreted through open-ended questions and observations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• mild to moderate dementia

• no severe hearing and visual impairment or motor problems

Exclusion Criteria:

• no formal caregiver

• no informal caregiver

Related Conditions & MeSH terms

• Dementia
• Older People

Intervention

Other:
• SOUND Intervention
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.

Locations

Country	Name	City	State
Italy	INRCA Hospital	Ancona
Portugal	Sons do Estamine Associacao	Trofa
Romania	Associatia Habilitas	Bucarest

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani	European Union

Countries where clinical trial is conducted

Italy,  Portugal,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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