An interventional study of Consultation and Online Support in Frailty, Sarcopenia and Aging, sponsored by Aberystwyth University. Completed at 1 site in United Kingdom. Open to participants aged 60 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Aberystwyth University · Not applicable, Interventional, and Prevention
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.
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.
1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.
This study's enrollment of 43 is below the median of 80 across 704 interventional studies indexed under Frailty.
Browse Frailty studies →Aberystwyth University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
Behavioral: Consultation · Behavioral: 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.
Behavioral: Consultation
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.
Behavioral: Consultation · Behavioral: Online Support · Behavioral: Empowered
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.
Behavioral: Consultation · Behavioral: Empowered
The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
Also known as: Diet, exercise and physical activity advice
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.
The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.
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
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
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
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
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
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
Grip Strength
Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength
Time frame: 3 months
Six Minute Walking Performance
Quantifies the distance able to walk during six minutes
Time frame: 3 months
Recruitment was done via invitation of existing database from our Research Unit, word of mouth and local advertising and promotion.
| Milestone | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| Started | 10 | 11 | 10 | 11 |
| Completed | 10 | 10 | 9 | 11 |
| Not completed | 0 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 | 0 |
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.
| Participants | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| Pilot Evaluation - Percentage of Participants Retained at Follow up | 10 | 10 | 9 | 11 |
Scored with the total score ( range of 14-70), and higher scores reflecting better well-being.
| score on a scale | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | 55 ± 7 | 54 ± 8 | 53 ± 7 | 50 ± 11 |
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..
| score on a scale | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| Short Physical Performance Battery | 11.4 ± 1.0 | 10.3 ± 2.5 | 10.4 ± 3.0 | 11.1 ± 1.0 |
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
| units on a scale | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| SNAQ -Dietary Analysis | 16 ± 2.1 | 15.6 ± 2.3 | 17.4 ± 1.1 | 16.4 ± 2.4 |
The ability to get up from a chair, walk three meters to turn around a cone, and return to sit down again.
| seconds | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| Timed-up-and go | 7.11 ± 1.56 | 10.55 ± 7.04 | 10.00 ± 9.31 | 8.46 ± 2.29 |
the Quality of Life Short Form -36. Scored with the total score (0-100), and higher scores reflecting better quality of life.
| units on a scale | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| Quality of Life SF36 | 72 ± 21 | 69 ± 19 | 64 ± 18 | 60 ± 19 |
Measured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength
| kilogram | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| Grip Strength | 30.0 ± 3.7 | 24.7 ± 7.6 | 28.0 ± 9.4 | 27.4 ± 8.1 |
Quantifies the distance able to walk during six minutes
| meter | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| Six Minute Walking Performance | 480 ± 89 | 396 ± 102 | 407 ± 163 | 439 ± 102 |
Collected over Three months, the duration of the intervention and the time between baseline and follow up assessment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Professional Led With Online Support | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Professional Led Without Online Support | 0/11 (0%) | 3/11 (27.3%) | 3/11 (27.3%) |
| Patient Empowered With Online Support | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Patient Empowered Without Online Support | 0/11 (0%) | 3/11 (27.3%) | 2/11 (18.2%) |
| Event | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| Hernia operation and complicationsMusculoskeletal and connective tissue disorders | 0/10 | 1/11 | 0/10 | 0/11 |
| Progressed into disability and houseboundGeneral disorders | 0/10 | 1/11 | 0/10 | 0/11 |
| Sepsis and bowel abscessGastrointestinal disorders | 0/10 | 0/11 | 0/10 | 1/11 |
| Hip replacement surgeryMusculoskeletal and connective tissue disorders | 0/10 | 1/11 | 0/10 | 0/11 |
| Mental ill-health: stressPsychiatric disorders | 0/10 | 0/11 | 0/10 | 1/11 |
| DiarrhoeaGastrointestinal disorders | 0/10 | 0/11 | 0/10 | 1/11 |
| Event | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support |
|---|---|---|---|---|
| PainMusculoskeletal and connective tissue disorders | 1/10 | 1/11 | 0/10 | 2/11 |
| Muscle InjuryMusculoskeletal and connective tissue disorders | 0/10 | 1/11 | 1/10 | 0/11 |
| FallGeneral disorders | 0/10 | 1/11 | 0/10 | 0/11 |
Two participants removed as part of the analysis as part of the pilot project. One participant was in Patient Empowered with Online Support (lost to follow up), and another one in Professional led without online support (lost to follow up). Another participant was excluded before group allocation due to not meeting the eligibility criteria identified during the pre-enrolment meeting. In total, 43 participants were recruited.
| Age, Categorical(Participants) | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 1 | 1 | 3 |
| >=65 years | 9 | 11 | 9 | 10 | 39 |
| Age, Continuous(years) | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support | Total |
|---|---|---|---|---|---|
| Mean | 74 ± 6 | 81 ± 4 | 74 ± 8 | 75 ± 6 | 76 ± 7 |
| Age, Customized(Participants) | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support | Total |
|---|---|---|---|---|---|
| 60-70 | 2 | 0 | 3 | 1 | 6 |
| 70-80 | 6 | 4 | 3 | 7 | 20 |
| 80-90 | 2 | 7 | 4 | 3 | 16 |
| Sex: Female, Male(Participants) | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support | Total |
|---|---|---|---|---|---|
| Female | 7 | 8 | 9 | 9 | 33 |
| Male | 3 | 3 | 1 | 2 | 9 |
| Race and Ethnicity Not Collected(Participants) | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(participants) | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support | Total |
|---|---|---|---|---|---|
| United Kingdom | 10 | 11 | 10 | 11 | 42 |
| Warwick and Edinburgh Mental Well-being Scale(score on a scale) | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support | Total |
|---|---|---|---|---|---|
| Mean | 58 ± 5 | 55 ± 5 | 52 ± 5 | 47 ± 12 | 53 ± 9 |
| Short Physical Performance Battery(score on a scale) | Professional Led With Online Support | Professional Led Without Online Support | Patient Empowered With Online Support | Patient Empowered Without Online Support | Total |
|---|---|---|---|---|---|
| Mean | 11.1 ± 1.1 | 10.4 ± 1.5 | 10.7 ± 1.6 | 10.1 ± 1.4 | 10.6 ± 1.4 |
5 further baseline measures are reported on the registry.
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Aberystwyth University