Frailty, Sarcopenia, Aging
Conditions
Keywords
well-being, exercise, physical activity, nutrition, gait
Brief summary
This study is looking at whether older people could benefit from an online monitoring platform to support their individual ambitions to maintain or improve functional ability. It is hypothesized this will enable the individual to monitor themselves periodically, obtain feedback about their functional ability, receive recommended diet, exercise and physical activity interventions and record the adherence to any intervention. All information can be linked back to the health care professional for official support and intervene when a decline is noticed, in order to prevent frailty from developing. The aim of this study is to find out if providing more support and greater empowerment can help older people improve their functional ability by self-monitoring and personalised interventions.
Detailed description
Participants will be individually randomised using randomisation service on a 1:1 allocation ratio to either group. There will be 4 groups, with differences in the consultation design and online support available. Participant assessments consists of questionnaires and physical tasks completed during two visits at the university facilities. During the second visit, a one-hour consultation with a health care professional will take place to develop a twelve-week action plan to promote a healthier lifestyle. Frailty status will be defined from the Fried frailty phenotype criteria. Exercise status will be based on current physical activity levels and the Short Physical Performance Battery score derived from the chair-stands, gait speed and balance assessments. Participants in the experimental group will receive the assessment, and the consultation will aim to promote to empower them, plus access to the online support platform, termed 'FACET'. Participants in the empowerment groups are provided with a structured booklet prior to the consultation to help the participant actively contribute to their own intervention programme, whereas in the other groups,the professional will lead the consultation. Participants in the online support groups are provided with FACET, which will provide a diary of recommended activities to do, assessments to complete, as well as information about healthy lifestyles, diet and physical activity recommendations. Details on the recommended exercises and diet will be provided (including demonstrations and examples, also sourced from reputable websites) via FACET and will enable the participant to engage with them. The exercises require no special equipment and can be performed without professional supervision. Participants will be able to monitor themselves regularly and progress or amend recommendations to tailor their needs. Progress will also be monitored by the initial assessors and these can also amend the recommendations based on participant feedback. In short, FACET enables the participants in these groups to engage with their own intervention, amend it and set their own priorities, goals and targets, emphasising prudent health care principles. Participants in all groups are followed up after 12 weeks. Assessments will be completed face-to-face at the facilities, or at home, dependent upon the participant's needs.
Interventions
BEHAVIORALConsultation
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
BEHAVIORALOnline Support
The participant will have access to an online platform 'FACET', to monitor themselves periodically, obtain feedback about their functional ability, receive recommended diet, exercise and physical activity interventions and record the adherence to any intervention.
BEHAVIORALEmpowered
The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.
Sponsors
EIT Health
Aberystwyth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The participant is unaware of the other groups details. Assessor and investigator are not blinded due to the need for providing information to the participant about their group allocation in this pilot project
Intervention model description
Randomised; Interventional; Design type: Treatment, Complex Intervention, Physical, Rehabilitation
Eligibility
Sex/Gender
ALL
Age
60 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 60 years and over * Willingness to give informed consent, to be randomized to one of the study groups, and comply with all study requirements * Community dwelling, assisted living conditions or care home residents. * Ability to walk 10 m independently, or with support if using a cane or walker. * Ability to understand instructions regarding the use of the technology and execution of the exercise program.
Exclusion criteria
* Moderate/severe dementia at baseline (defined as Mini Mental State Examination \< 23), * Severe, disabling stroke at baseline within the previous 6 months (defined as new or previous stroke with Barthel Index \< 9), * Recent (\< 3 months prior randomisation) myocardial infarction, or unstable angina. * Currently undergoing treatment that includes exercise and diet advice by health professionals * Referred at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation) within the previous 6 months. * Currently taking part in another study or taken part in an intervention study in the previous six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery | 3 months | Consists of Walking speed, balance, and chair stand test performance. Scored based on a score of 0-4 on each test, which are then added. A total maximum score of 12 reflecting good physical performance and thus higher scores indicate better outcome.. |
| Pilot Evaluation - Percentage of Participants Retained at Follow up | 3 Months | Percentage of participants returned at follow up, reflects the ability to recruit and retain participants. Recruitment took place over a period of 3 months, to recruit 42 participants, with a recruitment rate of 14 participants per month. |
| Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | 3 months | Scored with the total score ( range of 14-70), and higher scores reflecting better well-being. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life SF36 | 3 months | the Quality of Life Short Form -36. Scored with the total score (0-100), and higher scores reflecting better quality of life. |
| Grip Strength | 3 months | Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength |
| SNAQ -Dietary Analysis | 3 months | The SNAQ was used to provide a single outcome variable for this. Was originally: Food diary and urine metabolomics for the ingestion of food components (meats, fish, legumes and fruits), with emphasis on the quantification of the total protein intake. SNAQ: Simplified Nutritional Appetite Questionnaire. Scale from 5-25, with higher scores indicating better outcome |
| Timed-up-and go | 3 months | The ability to get up from a chair, walk three meters to turn around a cone, and return to sit down again. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walking Performance | 3 months | Quantifies the distance able to walk during six minutes |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment was done via invitation of existing database from our Research Unit, word of mouth and local advertising and promotion.
Pre-assignment details
One participant was excluded from the study due to baseline disability status and withdrawal after enrolment is not included in this number. A total of 43 were thus reduced to 42. Four participants were re-allocated to 'no online support' arm due to lack of access to internet. One participant was re-allocated to 'Professional led' arm due to not engaging with Patient Empowered activities prior to second visit.
Participants by arm
| Arm | Count |
|---|---|
| Professional Led With Online Support The consultation is led by the professional and lifestyle recommendations are based on ViviFrail recommendations and personal experience of the professional.
The 12-week intervention includes access to an online monitoring platform. The online platform provides the lifestyle recommendations and consists of a diary of activities, examples of exercises, general advice and instructions for monitoring and self-assessment.
Consultation: The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Online Support: The participant will have access to an online platform 'FACET', to monitor themselves periodically, obtain feedback about their functional ability, receive recommended diet, exercise and physical activity interventions and record the adherence to any intervention. | 10 |
| Professional Led Without Online Support The consultation is led by the professional and lifestyle recommendations are based on ViviFrail recommendations and personal experience of the professional.
There is no access to the online monitoring platform, and lifestyle recommendations were provided on paper to the participant.
Consultation: The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual | 11 |
| Patient Empowered With Online Support The consultation is led by the participant, and started with the questions 'What matters to you', and 'What are your goals'. The professional based the lifestyle recommendations based on these responses.
The 12-week intervention includes access to an online monitoring platform. The online platform provides the lifestyle recommendations and consists of a diary of activities, examples of exercises, general advice and instructions for monitoring and self-assessment.
Consultation: The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Online Support: The participant will have access to an online platform 'FACET', to monitor themselves periodically, obtain feedback about their functional ability, receive recommended diet, exercise and physical activity interventions and record the adherence to any intervention.
Empowered: Actively encouraged to contribute to their own consultation | 10 |
| Patient Empowered Without Online Support The consultation is led by the participant, and started with the questions 'What matters to you', and 'What are your goals'. The professional based the lifestyle recommendations based on these responses.
There is no access to the online monitoring platform, and lifestyle recommendations were provided on paper to the participant.
Consultation: The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Empowered: The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan. | 11 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Professional Led With Online Support | Patient Empowered Without Online Support | Professional Led Without Online Support | Patient Empowered With Online Support |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 9 Participants | 10 Participants | 11 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Continuous | 76 years STANDARD_DEVIATION 7 | 74 years STANDARD_DEVIATION 6 | 75 years STANDARD_DEVIATION 6 | 81 years STANDARD_DEVIATION 4 | 74 years STANDARD_DEVIATION 8 |
| Age, Customized 60-70 | 6 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Age, Customized 70-80 | 20 Participants | 6 Participants | 7 Participants | 4 Participants | 3 Participants |
| Age, Customized 80-90 | 16 Participants | 2 Participants | 3 Participants | 7 Participants | 4 Participants |
| Grip Strength | 27.0 kilogram STANDARD_DEVIATION 7.9 | 28.6 kilogram STANDARD_DEVIATION 4.1 | 26.8 kilogram STANDARD_DEVIATION 9.1 | 24.5 kilogram STANDARD_DEVIATION 8.9 | 28.4 kilogram STANDARD_DEVIATION 8.9 |
| Quality of Life SF36 | 66 units on a scale STANDARD_DEVIATION 17 | 73 units on a scale STANDARD_DEVIATION 14 | 62 units on a scale STANDARD_DEVIATION 19 | 66 units on a scale STANDARD_DEVIATION 19 | 59 units on a scale STANDARD_DEVIATION 16 |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United Kingdom | 42 participants | 10 participants | 11 participants | 11 participants | 10 participants |
| Sex: Female, Male Female | 33 Participants | 7 Participants | 9 Participants | 8 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants |
| Short Physical Performance Battery | 10.6 score on a scale STANDARD_DEVIATION 1.4 | 11.1 score on a scale STANDARD_DEVIATION 1.1 | 10.1 score on a scale STANDARD_DEVIATION 1.4 | 10.4 score on a scale STANDARD_DEVIATION 1.5 | 10.7 score on a scale STANDARD_DEVIATION 1.6 |
| Six Minute Walking Performance | 416 meter STANDARD_DEVIATION 99 | 446 meter STANDARD_DEVIATION 90 | 441 meter STANDARD_DEVIATION 71 | 393 meter STANDARD_DEVIATION 96 | 377 meter STANDARD_DEVIATION 129 |
| SNAQ - Dietary Analysis | 16.3 units on a scale STANDARD_DEVIATION 1.8 | 15.8 units on a scale STANDARD_DEVIATION 1.9 | 16 units on a scale STANDARD_DEVIATION 2.1 | 16.4 units on a scale STANDARD_DEVIATION 1.8 | 17.1 units on a scale STANDARD_DEVIATION 0.9 |
| Timed-up-and go | 9.54 seconds STANDARD_DEVIATION 5.01 | 7.70 seconds STANDARD_DEVIATION 1.96 | 10.15 seconds STANDARD_DEVIATION 2.73 | 9.41 seconds STANDARD_DEVIATION 2.86 | 10.98 seconds STANDARD_DEVIATION 9.61 |
| Warwick and Edinburgh Mental Well-being Scale | 53 score on a scale STANDARD_DEVIATION 9 | 58 score on a scale STANDARD_DEVIATION 5 | 47 score on a scale STANDARD_DEVIATION 12 | 55 score on a scale STANDARD_DEVIATION 5 | 52 score on a scale STANDARD_DEVIATION 5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 1 / 10 | 3 / 11 | 1 / 10 | 2 / 11 |
| serious Total, serious adverse events | 0 / 10 | 3 / 11 | 0 / 10 | 3 / 11 |
Outcome results
Primary
Pilot Evaluation - Percentage of Participants Retained at Follow up
Percentage of participants returned at follow up, reflects the ability to recruit and retain participants. Recruitment took place over a period of 3 months, to recruit 42 participants, with a recruitment rate of 14 participants per month.
Time frame: 3 Months
Population: A total of 105 people were actively approached, but the project was also promoted via word of mouth and public recruitment interactions and flyers in the local area.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Professional Led With Online Support | Pilot Evaluation - Percentage of Participants Retained at Follow up | 10 Participants |
| Professional Led Without Online Support | Pilot Evaluation - Percentage of Participants Retained at Follow up | 10 Participants |
| Patient Empowered With Online Support | Pilot Evaluation - Percentage of Participants Retained at Follow up | 9 Participants |
| Patient Empowered Without Online Support | Pilot Evaluation - Percentage of Participants Retained at Follow up | 11 Participants |
Primary
Short Physical Performance Battery
Consists of Walking speed, balance, and chair stand test performance. Scored based on a score of 0-4 on each test, which are then added. A total maximum score of 12 reflecting good physical performance and thus higher scores indicate better outcome..
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Professional Led With Online Support | Short Physical Performance Battery | 11.4 score on a scale | Standard Deviation 1 |
| Professional Led Without Online Support | Short Physical Performance Battery | 10.3 score on a scale | Standard Deviation 2.5 |
| Patient Empowered With Online Support | Short Physical Performance Battery | 10.4 score on a scale | Standard Deviation 3 |
| Patient Empowered Without Online Support | Short Physical Performance Battery | 11.1 score on a scale | Standard Deviation 1 |
Comparison: Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.
Primary
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Scored with the total score ( range of 14-70), and higher scores reflecting better well-being.
Time frame: 3 months
Population: Incomplete questionnaires were present and excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Professional Led With Online Support | Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | 55 score on a scale | Standard Deviation 7 |
| Professional Led Without Online Support | Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | 54 score on a scale | Standard Deviation 8 |
| Patient Empowered With Online Support | Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | 53 score on a scale | Standard Deviation 7 |
| Patient Empowered Without Online Support | Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | 50 score on a scale | Standard Deviation 11 |
Comparison: Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.
Secondary
Grip Strength
Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Professional Led With Online Support | Grip Strength | 30.0 kilogram | Standard Deviation 3.7 |
| Professional Led Without Online Support | Grip Strength | 24.7 kilogram | Standard Deviation 7.6 |
| Patient Empowered With Online Support | Grip Strength | 28.0 kilogram | Standard Deviation 9.4 |
| Patient Empowered Without Online Support | Grip Strength | 27.4 kilogram | Standard Deviation 8.1 |
Secondary
Quality of Life SF36
the Quality of Life Short Form -36. Scored with the total score (0-100), and higher scores reflecting better quality of life.
Time frame: 3 months
Population: Incomplete questionnaires were present and excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Professional Led With Online Support | Quality of Life SF36 | 72 units on a scale | Standard Deviation 21 |
| Professional Led Without Online Support | Quality of Life SF36 | 69 units on a scale | Standard Deviation 19 |
| Patient Empowered With Online Support | Quality of Life SF36 | 64 units on a scale | Standard Deviation 18 |
| Patient Empowered Without Online Support | Quality of Life SF36 | 60 units on a scale | Standard Deviation 19 |
Secondary
SNAQ -Dietary Analysis
The SNAQ was used to provide a single outcome variable for this. Was originally: Food diary and urine metabolomics for the ingestion of food components (meats, fish, legumes and fruits), with emphasis on the quantification of the total protein intake. SNAQ: Simplified Nutritional Appetite Questionnaire. Scale from 5-25, with higher scores indicating better outcome
Time frame: 3 months
Population: Incomplete questionnaires were present and excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Professional Led With Online Support | SNAQ -Dietary Analysis | 16 units on a scale | Standard Deviation 2.1 |
| Professional Led Without Online Support | SNAQ -Dietary Analysis | 15.6 units on a scale | Standard Deviation 2.3 |
| Patient Empowered With Online Support | SNAQ -Dietary Analysis | 17.4 units on a scale | Standard Deviation 1.1 |
| Patient Empowered Without Online Support | SNAQ -Dietary Analysis | 16.4 units on a scale | Standard Deviation 2.4 |
Secondary
Timed-up-and go
The ability to get up from a chair, walk three meters to turn around a cone, and return to sit down again.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Professional Led With Online Support | Timed-up-and go | 7.11 seconds | Standard Deviation 1.56 |
| Professional Led Without Online Support | Timed-up-and go | 10.55 seconds | Standard Deviation 7.04 |
| Patient Empowered With Online Support | Timed-up-and go | 10.00 seconds | Standard Deviation 9.31 |
| Patient Empowered Without Online Support | Timed-up-and go | 8.46 seconds | Standard Deviation 2.29 |
Other Pre-specified
Six Minute Walking Performance
Quantifies the distance able to walk during six minutes
Time frame: 3 months
Population: Some participants opted out of completing the task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Professional Led With Online Support | Six Minute Walking Performance | 480 meter | Standard Deviation 89 |
| Professional Led Without Online Support | Six Minute Walking Performance | 396 meter | Standard Deviation 102 |
| Patient Empowered With Online Support | Six Minute Walking Performance | 407 meter | Standard Deviation 163 |
| Patient Empowered Without Online Support | Six Minute Walking Performance | 439 meter | Standard Deviation 102 |