danceSing Care Evaluation: Testing the Feasibility

Aging Clinical Trial

Official title:

A Realist Evaluation of the Feasibility of a Digital Music and Movement Intervention for Older People Living in Care Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559203
• Other study ID #: NICR 3735
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2022
• Source: University of Stirling
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• The investigators wanted to find out if digital music and movement resources could be delivered in care homes. They rolled out a 12-week programme to 10 care homes and had 47 care home residents participate in the research.

• The investigators also wanted to find out under what circumstances the digital music and movement resources would be most effective for the health and wellbeing of the care home residents.

• A survey measuring the number of falls in the past three months, activities of daily living and health, psychosocial wellbeing (anxiety, depression, stress and loneliness), sleep satisfaction and frailty measures such as appetite and weight loss) was completed before and after the intervention. Also, interviews with residents and focus groups with staff were done after the intervention to find out how they felt about the programme.

Description:

The specific research objectives were to evaluate the following topics:

1. Feasibility: was the activity implemented and/or delivered as planned? Were the resources suitable for this setting? Were adherence rates at an acceptable level?

2. Context: what is the role of the care homes in providing resources to the ACs? In what circumstances would the programme have worked most efficiently? What were the potential barriers for care homes or ACs to provide these resources?

3. Mechanism: what underlying mechanisms made the danceSing Care programme work (or not)? Was it the situational context or the programme context?

4. Outcome: What were the results? Were the outcomes adequate and realistic for this programme?

5. Moderators: were moderating factors responsible? By moderating factors, we are referring to contextual factors that are out of the program's control but may help or hinder the achievement of the outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• residents in care homes = 65 years,

• able to complete 12 weeks of a movement and music program,

• having the capacity to give informed consent.

Exclusion Criteria:

• currently taking part in any other clinical trial which could potentially have an impact upon or influence the findings of the current study,

• pre-existing conditions or concurrent diagnoses which would profoundly impact their capacity to undergo the intervention, even once adaptations have been made,

• inability to understand written/spoken English adequately to participate in the measures and intervention (e.g., due to cognitive or sensory impairment).

Related Conditions & MeSH terms

• Aged
• Aging
• Healthy Aging
• Older Adults

Intervention

Behavioral:
• danceSing Care
The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.

Locations

Country	Name	City	State
United Kingdom	Balhousie Care Group	Perth

Sponsors (1)

Lead Sponsor	Collaborator
University of Stirling

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' programme adherence assessed by attendance files	The activity coordinators will fill in participants' adherence after each session. The completed files will be sent through to the investigators.	Will be evaluated after completion of the 12-week intervention period
Primary	Number of sessions delivered, assessed by attendance files	The activity coordinators will fill in participants' adherence after each session. The completed files will be sent through to the investigators.	Will be evaluated after completion after the completion of the 12-week intervention period
Primary	Acceptability of the intervention assessed by focus groups	The investigators will conduct focus groups with the involved activity coordinators in the care home to assess acceptability.	1 month after completion after the completion of the 12-week intervention period
Primary	Acceptability of the intervention assessed by interviews	The investigators will conduct interviews with the participants in the care home to assess acceptability.	1 month after completion after the completion of the 12-week intervention period
Secondary	Participant's Fear of falling using the Falls Efficacy Scale - International (short form)(FES-I)	It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).	Before and 1 month after completion of the 12-week intervention period
Secondary	Participant's Activities of daily living and health-related quality of life using The Dartmouth COOP charts	5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of "1" = no impairment, "5" = most impaired.	Before and 1 month after completion of the 12-week intervention period
Secondary	Participant's Activities of daily living and health-related quality of life using EQ-5D-3L	The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, with higher scores describing worse outcomes.	Before and 1 month after completion of the 12-week intervention period
Secondary	Participant's Psychosocial wellbeing using the Hospital Anxiety and Depression Scale (HADS)	The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.	Before and 1 month after completion of the 12-week intervention period
Secondary	Participant's Psychosocial wellbeing using the Perceived Stress Scale (PSS)	Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	Before and 1 month after completion of the 12-week intervention period
Secondary	Participant's Psychosocial wellbeing using the brief UCLA loneliness scale (ULS-6)	Using a 4-point rating scale (1= never; 4 = always), participants answer 6 questions, such as "How often do you feel left out?" and "How often do you feel part of a group of friends?".	Before and 1 month after completion of the 12-week intervention period
Secondary	Participant's Sleep satisfaction using the National Sleep Foundation's Sleep Satisfaction Tool (SST)	9-item questionnaire (scoring 1 not satisfied to 4 very satisfied) to assesses the general population's sleep satisfaction.	Before and 1 month after completion of the 12-week intervention period
Secondary	Participant's Appetite using the Simplified Nutritional Appetite Questionnaire (SNAQ)	This is used for limited frailty testing, a self-assessment nutritional screening tool that predicts weight loss, scoring 1 (very poor) to 4 (very good) on appetite-related topics.	Before and 1 month after completion of the 12-week intervention period
Secondary	Participant's unintended weight loss using the weight loss item from the Fried Frailty Scale	This is used for limited frailty testing, asking participants if they lost more than 4.5kg unintentionally the last year.	Before and 1 month after completion of the 12-week intervention period