Clinical trial NCT04851028: MusiCare: Music Therapy & Innovative Technology
Official title: MusiCare: Protecting Cognitive Functions and Wellbeing Using Music Therapy & Innovative Technology With an Aging Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Aging
Cognitive Impairment
Keywords: music therapy
aging
cognitive function
robotics
Lead sponsor: Middlesex University
Sponsor class: OTHER
Collaborators: name: The Dunhill Medical Trust
name: University of Padova
name: Vrije Universiteit Brussel
name: University of Dublin, Trinity College
First posted: 2021-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The number of older people living with cognitive impairment or dementia has increased the need for simple, inexpensive interventions to improve the quality of life for such individuals and their families. Policy-makers sensitive to issues associated with mental health challenges in aging have embraced social prescribing, and a wealth of research has flourished to study non-pharmacological forms of preventative intervention. Can music-therapy(MT) be one of them? Different studies demonstrated that music stimulates a range of cognitive and social functions. However, scientific studies assessing the value of MT for those who need support in later life are limited, and rigorous research is required to generate robust scientific evidence. The focus of this study is on developing novel forms of intervention for older adults who are healthy or experiencing mild-to-moderate cognitive decline, aiming at \[i\]understanding whether MT could be used in preventive programs to support cognitive functions, \[ii\]identifying the best match between types of MT and levels of cognitive decline. Moreover, recent developments of Robotic-Assistance-Technologies offer opportunities to explore how such technologies may be used to contribute to older adults wellbeing when integrated within care routines to facilitate MT delivery.

Spanning across three-studies, the investigators will examine psychosocial benefits of 5-month MT interventions (one2one vs small-group MT) in healthy older adults and impaired older adults in care homes, compared to standard care. This latter group will receive MT afterwards. Further, researchers will investigate whether Robotic-Assistance-Technologies may enrich MT interventions and have additional benefits for the participants and translatability for community-based services.

In order to measure these effects, psychological (cognitive functions, wellbeing, quality of life) and physiological (hormonal, cardiovascular \& brain activity) measures will be compared before/after the intervention.

The study will elucidate relationships between different types of MT and benefits to participants wellbeing, cognitive functions \& social engagement, as well as the impact of robotic assistive technologies in public health services and social care.

Detailed description: The following objectives are addressed:

\[Oi\] Identifying a consistent set of convergent measures for the reliable assessment of cognition/well-being in MT studies integrating psychological measures with biomarkers; \[Oii\] Implementing robust MT protocols benefitting cognitive functions/well-being in ageing individuals with varying cognitive ability; \[Oiii\] Comparing the outcomes of one2one/small-group MT intervention in function of participants' cognitive abilities (ranging from healthy ageing to moderate impairment); \[Oiv\] Devising, implementing and testing a robotic platform associated with MT to facilitate therapists/caregivers' work through novel forms of interaction with ageing individuals, and potential translatability to communities.

Our research questions/hypotheses are:

\[H1\] Will MT benefits healthy, mildly and moderately impaired 65+ in outcome measures? MT \> standard care.

\[H2\] Which MT treatment (one2one/small group) is more effective in function of older adults' cognitive level? Best outcomes predicted as follows: healthy 65+ with small-group MT; for mildly impaired 65+, one2one = small-group MT; moderately impaired 65+ with one2one MT.

\[H3\] Will improvements in cognitive functions derived from MT be associated with psychophysiological biomarkers? Convergent measures will be identified linking cognitive, behavioural and physiological improvement.

\[H4\] What are the benefits of MT for caregivers? A reduction in participant psychiatric and depressive symptoms will correspond to caregivers' workload and stress perception decrease.

\[H5\] Are there benefits from enriching MT with robotic technology? Specifically, the investigators hypothesize that a) the robot will have the capability of delivering interactive music training sessions, with the support of caregivers not specialised in MT and b) the continuous monitoring provided by the robotic platform will enhance the information available to therapists/caregivers without significantly burdening them.

MusiCare aims are:

\[Ai\] Provide care-homes, communities and policy-makers with clear guidelines concerning the utility, suitability and cost-effectiveness of Music Therapy (MT) interventions (one2one vs small-group) as a prevention/rehabilitation method suitable for social prescribing and support for positive ageing.

\[Aii\] Provide music therapists with robust protocols, new tests specifically designed to work through musical tasks (Music Cognitive Test).

\[Aiii\] Provide scholars/practitioners with a range of objective measures to select from, depending on their needs, in order to evaluate MT interventions in ageing.

\[Aiv\] Explore how the assistive robotic technologies can enrich MT in care-home settings by empowering care-home staff with a new active role in assisting rehabilitative activities as well as facilitating inter-generational communication between families and ageing relatives.

\[Av\] Increase public awareness about healthy ageing, and arts \& wellbeing.

Eligibility criteria: Inclusion Criteria:

* Aged ≥65yrs
* No significant hearing impairment that would negatively interfere with the music-based interventions
* Fluent in English
* Healthy group - MMSE ≥ 24
* Cognitive impairment: mild MMSE= 18-23, moderate MMSE= 10-17

Exclusion Criteria:

* Presence of severe motor deficits that would not allow individuals to participate in the intervention
* Having taken part in a cognitive training programme or Music Therapy programme within the last 6 months.

Primary outcomes:
measure: General cognitive functions change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline vs. post- intervention period (time 0/+5-months)
measure: Music related cognitive function change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline vs. post- intervention period (time 0/+5-months)
measure: Attentional functions change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline vs. post- intervention period (time 0/+5-months)
measure: Executive and spatial-cognitive abilities change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline vs. post- intervention period (time 0/+5-months)
Secondary outcomes:
measure: Quality of Life change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline vs. post- intervention period (time 0/+5-months)
measure: Mood Index change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline vs. post- intervention period (time 0/+5-months)
measure: Neuro-psychiatric symptoms change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline vs. post- intervention period (time 0/+5-months)
measure: Cognitive reserve
timeFrame: Baseline (i.e., time 0)
Other outcomes:
measure: Salivary Hormones index (cortisol/DHEA ratio) change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline vs. post- intervention period (time 0/+5-months)
measure: Salivary Hormones index (cortisol/DHEA ratio) change from baseline/mid-intervention(i.e., time 0/+10 weeks)
timeFrame: Baseline vs. mid-intervention period (time 0/+10 weeks)
measure: Salivary Hormones index (cortisol/DHEA ratio) change from mid-/post-intervention (i.e., 10weeks/5 months)
timeFrame: Mid-intervention period (10 weeks) vs. post-intervention (5 months)
measure: RSA change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline and post- intervention period (time 0/+5-months)
measure: EEG change from baseline/post (i.e., time 0/+5 months)
timeFrame: Baseline and post- intervention period (time 0/+5-months)
Locations:
city: Derby
country: United Kingdom
facility: MHA Methodist Homes
Study officials:
affiliation: Middlesex University
name: Fabia Franco, PhD
role: PRINCIPAL_INVESTIGATOR
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