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Completed

NCT Number: NCT06320093

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INRCA Hospital, Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no formal caregiver
  • no informal caregiver

Treatment and study plan

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.

Primary outcomes

  1. Change in mental wellbeing of patients with dementia

    Time frame: baseline, 12 and 14 weeks later

    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.

  2. Change in cognitive status of patients with dementia

    Time frame: baseline, 12 and 14 weeks later

    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.

  3. Change in stress of health care providers

    Time frame: baseline, 12 and 14 weeks later

    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.

Sponsors and collaborators

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Other

Collaborators

  • European Union

Registry information

Acronym: SOUND

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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