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The specific research objectives were to evaluate the following topics:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Digital music and movement resources. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danceSing Care | Behavioral | The programme was a digital movement and music programme with resources from danceSing Care 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants' Programme Adherence as % Sessions Attended Out of the Possible Maximum Number of Sessions Delivered Per Care Home Aggregated as % Across All Care Homes. | The activity coordinators will fill in participants' adherence after each session. The completed files will be sent through to the investigators. Individual participants' adherence is calculated as the number of sessions they individually attended out of the possible number of sessions available to them in their care home. This is reported as the percentage of attended sessions per person per care home out of those delivered averaged per care home then aggregated across all care homes. | Will be evaluated after completion of the 12-week intervention period |
| 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 |
| Acceptability of the Intervention Assessed by Focus Groups - Semi-structured Questions Covering Subjective Views on Enjoyment, Motivation, Duration, Content Etc. | Investigators will conduct focus groups with the activity coordinators to assess acceptability of the intervention. Guide questions included: Did you enjoy using the danceSing Care online activities? Did you manage to take part in the 3+1 sessions a week? If not, why? Would you say duration of sessions was appropriate? Did you complete most of sessions or have to stop at any point? What did you like about the DSC activities? Was there anything you did not like? If you could change something about this programme to make it work effectively here, what would you change and why? Why did you take part? What made you continue to take part? What do you consider the outcomes of this program to have been for you? Would you like to carry on engaging in the DSC activities? Why/why not? Do you feel part of the DSC family/champions? Has engaging in the DSC activities brought you closer to other residents and staff? | 1 month after completion after the completion of the 12-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fear of Falling Between Baseline and Within One Month of Completing the Intervention 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). | Baseline and within 1 month of completion of the 12-week intervention period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Whittaker | University of Stirling | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balhousie Care Group | Perth | PH1 1RA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36879201 | Result | Ofosu EF, De Nys L, Connelly J, Ryde GC, Whittaker AC. A realist evaluation of the feasibility of a randomised controlled trial of a digital music and movement intervention for older people living in care homes. BMC Geriatr. 2023 Mar 6;23(1):125. doi: 10.1186/s12877-023-03794-5. |
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did not meet age inclusion criterion
2 did not meet eligibility criteria resulting in 47 participants enrolled across 10 care homes
| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Trial - Intervention Group n = 47 Participants Were Allocated the Intervention | Digital music and movement resources. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
older adults living in residential care homes - Scotland
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group n = 47 Allocated | Digital music and movement resources. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants' Programme Adherence as % Sessions Attended Out of the Possible Maximum Number of Sessions Delivered Per Care Home Aggregated as % Across All Care Homes. | The activity coordinators will fill in participants' adherence after each session. The completed files will be sent through to the investigators. Individual participants' adherence is calculated as the number of sessions they individually attended out of the possible number of sessions available to them in their care home. This is reported as the percentage of attended sessions per person per care home out of those delivered averaged per care home then aggregated across all care homes. | calculates the number of sessions attended on average out of the possible maximum number of sessions delivered | Posted | Count of Units | Delivered Sessions | Will be evaluated after completion of the 12-week intervention period | Delivered Sessions | Delivered Sessions |
|
12 weeks
fall resulting in serious injury/hospitalisation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group n = 47 Allocated | Digital music and movement resources. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Anna C. Whittaker | University of Stirling | 0178646 | 7816 | a.c.whittaker@stir.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2021 | Dec 3, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2021 | Sep 21, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Acceptability of the Intervention Assessed by Interviews - Semi-structured Questions Covering Subjective Views on Enjoyment, Motivation, Duration, Content Etc. | Investigators will conduct focus groups/interviews with residents to assess acceptability of the intervention. Guide questions included: Did you enjoy using the danceSing Care online activities? Did you manage to take part in the 3+1 sessions a week? If not, why? Would you say duration of sessions was appropriate? Did you complete most of sessions or have to stop at any point? What did you like about the DSC activities? Was there anything you did not like? If you could change something about this programme to make it work effectively here, what would you change and why? Why did you take part? What made you continue to take part? What do you consider the outcomes of this program to have been for you? Would you like to carry on engaging in the DSC activities? Why/why not? Do you feel part of the DSC family/champions? Has engaging in the DSC activities brought you closer to other residents and staff? | 1 month after completion after the completion of the 12-week intervention period |
| Change in Participant's Activities of Daily Living and Health-related Quality of Life From Baseline to Within One Month of the Completion of the Intervention Using The Dartmouth COOP Charts | Change in participant's Activities of daily living and health-related quality of life from baseline to within one month of the completion of the intervention using The Dartmouth COOP which has 5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of "1" = no impairment, "5" = most impaired. | Baseline and within 1 month of completion of the 12-week intervention period |
| Change in Participant's Activities of Daily Living and Health-related Quality of Life From Baseline to Within One Month of Completing the Intervention Using EQ-5D-3L | The EQ-5D-3L descriptive system comprises the following five questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has a 3-point scale for rating it: no problems, some problems, and extreme problems (1-3). 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 are then combined to describe the patient's health state, with a higher TOTAL score describing a worse outcome. The range for total score is 5-15. | Baseline and within 1 month of completion of the 12-week intervention period |
| Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention 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. No total score is reported. Anxiety and Depression sub-scale totals are calculated separately by summing responses to the applicable 7 items each. The range for each sub-scale is 0-21. A higher score indicates a worse outcome. | Baseline and within 1 month of completion of the 12-week intervention period |
| Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention Using the Perceived Stress Scale (PSS) | Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | Baseline and within 1 month of completion of the 12-week intervention period |
| Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention 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?". The Brief UCLA Loneliness scale is summed across items to give one total score. The range for total score is 6-24. A higher score indicates worse loneliness, i.e. a worse outcome. | Baseline and within 1 month of completion of the 12-week intervention period |
| Change in Participant's Sleep Satisfaction From Baseline to Within One Month of Completing the Intervention 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. The SST scale is summed across items to give one total score. The range for total score is 9-36. | Baseline and within 1 month of completion of the 12-week intervention period |
| Change in Participant's Appetite From Baseline to Within One Month of Completing the Intervention 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. | Baseline and within 1 month of completion of the 12-week intervention period |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Digital music and movement resources. 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. |
|
|
| 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. | Adherence across all carehomes allocated to the intervention, 7 delivered the intervention. Number of sessions delivered out of the recommended 48, then averaged across all 7 care homes. | Posted | Count of Units | Delivered Sessions | Will be evaluated after completion after the completion of the 12-week intervention period | Delivered Sessions | Delivered Sessions |
|
|
|
| Primary | Acceptability of the Intervention Assessed by Focus Groups - Semi-structured Questions Covering Subjective Views on Enjoyment, Motivation, Duration, Content Etc. | Investigators will conduct focus groups with the activity coordinators to assess acceptability of the intervention. Guide questions included: Did you enjoy using the danceSing Care online activities? Did you manage to take part in the 3+1 sessions a week? If not, why? Would you say duration of sessions was appropriate? Did you complete most of sessions or have to stop at any point? What did you like about the DSC activities? Was there anything you did not like? If you could change something about this programme to make it work effectively here, what would you change and why? Why did you take part? What made you continue to take part? What do you consider the outcomes of this program to have been for you? Would you like to carry on engaging in the DSC activities? Why/why not? Do you feel part of the DSC family/champions? Has engaging in the DSC activities brought you closer to other residents and staff? | Five core themes emerged from 2 focus groups with 5 activity coordinators (care staff) across 2 focus groups. Exemplar quotes are given in the publication from this study. | Posted | Count of Units | qualitative themes | 1 month after completion after the completion of the 12-week intervention period | qualitative themes | qualitative themes |
|
|
|
| Primary | Acceptability of the Intervention Assessed by Interviews - Semi-structured Questions Covering Subjective Views on Enjoyment, Motivation, Duration, Content Etc. | Investigators will conduct focus groups/interviews with residents to assess acceptability of the intervention. Guide questions included: Did you enjoy using the danceSing Care online activities? Did you manage to take part in the 3+1 sessions a week? If not, why? Would you say duration of sessions was appropriate? Did you complete most of sessions or have to stop at any point? What did you like about the DSC activities? Was there anything you did not like? If you could change something about this programme to make it work effectively here, what would you change and why? Why did you take part? What made you continue to take part? What do you consider the outcomes of this program to have been for you? Would you like to carry on engaging in the DSC activities? Why/why not? Do you feel part of the DSC family/champions? Has engaging in the DSC activities brought you closer to other residents and staff? | 4 residents in 4 semi-structured interviews. Exemplar quotes are in the publication of the study. | Posted | Count of Units | qualitative themes | 1 month after completion after the completion of the 12-week intervention period | qualitative themes | qualitative themes |
|
|
|
| Secondary | Change in Fear of Falling Between Baseline and Within One Month of Completing the Intervention 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). | Only 18 participants retained capacity to continue to consent and capacity to complete follow-up measures. Outcomes are mean difference from baseline to post-intervention. | Posted | Mean | 99% Confidence Interval | units on a scale | Baseline and within 1 month of completion of the 12-week intervention period |
|
|
|
|
| Secondary | Change in Participant's Activities of Daily Living and Health-related Quality of Life From Baseline to Within One Month of the Completion of the Intervention Using The Dartmouth COOP Charts | Change in participant's Activities of daily living and health-related quality of life from baseline to within one month of the completion of the intervention using The Dartmouth COOP which has 5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of "1" = no impairment, "5" = most impaired. | 18 with pre- and post-intervention data. Mean difference measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and within 1 month of completion of the 12-week intervention period |
|
|
|
|
| Secondary | Change in Participant's Activities of Daily Living and Health-related Quality of Life From Baseline to Within One Month of Completing the Intervention Using EQ-5D-3L | The EQ-5D-3L descriptive system comprises the following five questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has a 3-point scale for rating it: no problems, some problems, and extreme problems (1-3). 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 are then combined to describe the patient's health state, with a higher TOTAL score describing a worse outcome. The range for total score is 5-15. | 18 with pre- and post-intervention data. Mean difference measure between their TOTAL score at baseline and post-intervention. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and within 1 month of completion of the 12-week intervention period |
|
|
|
|
| Secondary | Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention 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. No total score is reported. Anxiety and Depression sub-scale totals are calculated separately by summing responses to the applicable 7 items each. The range for each sub-scale is 0-21. A higher score indicates a worse outcome. | 18 with pre- and post-intervention data. Mean difference measure. For anxiety and depression separately. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and within 1 month of completion of the 12-week intervention period |
|
|
|
|
| Secondary | Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention Using the Perceived Stress Scale (PSS) | Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | 18 with pre- and post-intervention data. Mean difference measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and within 1 month of completion of the 12-week intervention period |
|
|
|
|
| Secondary | Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention 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?". The Brief UCLA Loneliness scale is summed across items to give one total score. The range for total score is 6-24. A higher score indicates worse loneliness, i.e. a worse outcome. | 18 with pre- and post-intervention data. Mean difference measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and within 1 month of completion of the 12-week intervention period |
|
|
|
|
| Secondary | Change in Participant's Sleep Satisfaction From Baseline to Within One Month of Completing the Intervention 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. The SST scale is summed across items to give one total score. The range for total score is 9-36. | 18 with pre- and post-intervention data. Mean difference measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and within 1 month of completion of the 12-week intervention period |
|
|
|
|
| Secondary | Change in Participant's Appetite From Baseline to Within One Month of Completing the Intervention 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. | 18 with pre- and post-intervention data. Mean difference measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and within 1 month of completion of the 12-week intervention period |
|
|
|
|
| 3 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
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| Modifications |
|
| Future Refinements |
|
| Intervention Effects |
|
| Future Implementation |
|
| .002 |
| Equivalence |
0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention |