- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05559203
danceSing Care Evaluation: Testing the Feasibility
September 24, 2022 updated by: Len De Nys, University of Stirling
A Realist Evaluation of the Feasibility of a Digital Music and Movement Intervention for Older People Living in Care Homes
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The specific research objectives were to evaluate the following topics:
- Feasibility: was the activity implemented and/or delivered as planned? Were the resources suitable for this setting? Were adherence rates at an acceptable level?
- 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?
- Mechanism: what underlying mechanisms made the danceSing Care programme work (or not)? Was it the situational context or the programme context?
- Outcome: What were the results? Were the outcomes adequate and realistic for this programme?
- 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.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Perth, United Kingdom, PH1 1RA
- Balhousie Care Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Digital music and movement resources.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants' programme adherence assessed by attendance files
Time Frame: Will be evaluated after completion of the 12-week intervention period
|
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
|
Number of sessions delivered, assessed by attendance files
Time Frame: Will be evaluated after completion after the completion of the 12-week intervention period
|
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
|
Acceptability of the intervention assessed by focus groups
Time Frame: 1 month after completion after the completion of the 12-week intervention period
|
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
|
Acceptability of the intervention assessed by interviews
Time Frame: 1 month after completion after the completion of the 12-week intervention period
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant's Fear of falling using the Falls Efficacy Scale - International (short form)(FES-I)
Time Frame: Before and 1 month after completion of the 12-week intervention period
|
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
|
Participant's Activities of daily living and health-related quality of life using The Dartmouth COOP charts
Time Frame: Before and 1 month after completion of the 12-week intervention period
|
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
|
Participant's Activities of daily living and health-related quality of life using EQ-5D-3L
Time Frame: Before and 1 month after completion of the 12-week intervention period
|
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
|
Participant's Psychosocial wellbeing using the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Before and 1 month after completion of the 12-week intervention period
|
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
|
Participant's Psychosocial wellbeing using the Perceived Stress Scale (PSS)
Time Frame: Before and 1 month after completion of the 12-week intervention period
|
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
|
Participant's Psychosocial wellbeing using the brief UCLA loneliness scale (ULS-6)
Time Frame: Before and 1 month after completion of the 12-week intervention period
|
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
|
Participant's Sleep satisfaction using the National Sleep Foundation's Sleep Satisfaction Tool (SST)
Time Frame: Before and 1 month after completion of the 12-week intervention period
|
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
|
Participant's Appetite using the Simplified Nutritional Appetite Questionnaire (SNAQ)
Time Frame: Before and 1 month after completion of the 12-week intervention period
|
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
|
Participant's unintended weight loss using the weight loss item from the Fried Frailty Scale
Time Frame: Before and 1 month after completion of the 12-week intervention period
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna Whittaker, University of Stirling
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
September 8, 2022
First Submitted That Met QC Criteria
September 24, 2022
First Posted (Actual)
September 29, 2022
Study Record Updates
Last Update Posted (Actual)
September 29, 2022
Last Update Submitted That Met QC Criteria
September 24, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NICR 3735
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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