Trial Outcomes & Findings for FrAilty Care and wEll-funcTion in Community Dwelling Older Adults (NCT NCT03707145)
NCT ID: NCT03707145
Last Updated: 2024-10-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
3 Months
Results posted on
2024-10-21
Participant Flow
Recruitment was done via invitation of existing database from our Research Unit, word of mouth and local advertising and promotion.
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.
Participant milestones
| Measure |
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.
|
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
|
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
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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
|
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
|
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Professional Led With Online Support
n=10 Participants
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.
|
Professional Led Without Online Support
n=11 Participants
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
|
Patient Empowered With Online Support
n=10 Participants
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
|
Patient Empowered Without Online Support
n=11 Participants
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.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
3 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=10 Participants
|
11 Participants
n=11 Participants
|
9 Participants
n=10 Participants
|
10 Participants
n=11 Participants
|
39 Participants
n=42 Participants
|
|
Age, Continuous
|
74 years
STANDARD_DEVIATION 6 • n=10 Participants
|
81 years
STANDARD_DEVIATION 4 • n=11 Participants
|
74 years
STANDARD_DEVIATION 8 • n=10 Participants
|
75 years
STANDARD_DEVIATION 6 • n=11 Participants
|
76 years
STANDARD_DEVIATION 7 • n=42 Participants
|
|
Age, Customized
60-70
|
2 Participants
n=10 Participants
|
0 Participants
n=11 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=11 Participants
|
6 Participants
n=42 Participants
|
|
Age, Customized
70-80
|
6 Participants
n=10 Participants
|
4 Participants
n=11 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=11 Participants
|
20 Participants
n=42 Participants
|
|
Age, Customized
80-90
|
2 Participants
n=10 Participants
|
7 Participants
n=11 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=11 Participants
|
16 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=10 Participants
|
8 Participants
n=11 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=11 Participants
|
33 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
3 Participants
n=11 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=11 Participants
|
9 Participants
n=42 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
10 participants
n=10 Participants
|
11 participants
n=11 Participants
|
42 participants
n=42 Participants
|
|
Warwick and Edinburgh Mental Well-being Scale
|
58 score on a scale
STANDARD_DEVIATION 5 • n=9 Participants • Incomplete questionnaires were present and excluded from analysis.
|
55 score on a scale
STANDARD_DEVIATION 5 • n=8 Participants • Incomplete questionnaires were present and excluded from analysis.
|
52 score on a scale
STANDARD_DEVIATION 5 • n=9 Participants • Incomplete questionnaires were present and excluded from analysis.
|
47 score on a scale
STANDARD_DEVIATION 12 • n=10 Participants • Incomplete questionnaires were present and excluded from analysis.
|
53 score on a scale
STANDARD_DEVIATION 9 • n=36 Participants • Incomplete questionnaires were present and excluded from analysis.
|
|
Short Physical Performance Battery
|
11.1 score on a scale
STANDARD_DEVIATION 1.1 • n=10 Participants
|
10.4 score on a scale
STANDARD_DEVIATION 1.5 • n=11 Participants
|
10.7 score on a scale
STANDARD_DEVIATION 1.6 • n=10 Participants
|
10.1 score on a scale
STANDARD_DEVIATION 1.4 • n=11 Participants
|
10.6 score on a scale
STANDARD_DEVIATION 1.4 • n=42 Participants
|
|
SNAQ - Dietary Analysis
|
15.8 units on a scale
STANDARD_DEVIATION 1.9 • n=10 Participants • Incomplete questionnaires were present and excluded from analysis.
|
16.4 units on a scale
STANDARD_DEVIATION 1.8 • n=8 Participants • Incomplete questionnaires were present and excluded from analysis.
|
17.1 units on a scale
STANDARD_DEVIATION 0.9 • n=7 Participants • Incomplete questionnaires were present and excluded from analysis.
|
16 units on a scale
STANDARD_DEVIATION 2.1 • n=10 Participants • Incomplete questionnaires were present and excluded from analysis.
|
16.3 units on a scale
STANDARD_DEVIATION 1.8 • n=35 Participants • Incomplete questionnaires were present and excluded from analysis.
|
|
Timed-up-and go
|
7.70 seconds
STANDARD_DEVIATION 1.96 • n=10 Participants
|
9.41 seconds
STANDARD_DEVIATION 2.86 • n=11 Participants
|
10.98 seconds
STANDARD_DEVIATION 9.61 • n=10 Participants
|
10.15 seconds
STANDARD_DEVIATION 2.73 • n=11 Participants
|
9.54 seconds
STANDARD_DEVIATION 5.01 • n=42 Participants
|
|
Quality of Life SF36
|
73 units on a scale
STANDARD_DEVIATION 14 • n=9 Participants • Incomplete questionnaires were present and excluded from analysis.
|
66 units on a scale
STANDARD_DEVIATION 19 • n=8 Participants • Incomplete questionnaires were present and excluded from analysis.
|
59 units on a scale
STANDARD_DEVIATION 16 • n=7 Participants • Incomplete questionnaires were present and excluded from analysis.
|
62 units on a scale
STANDARD_DEVIATION 19 • n=9 Participants • Incomplete questionnaires were present and excluded from analysis.
|
66 units on a scale
STANDARD_DEVIATION 17 • n=33 Participants • Incomplete questionnaires were present and excluded from analysis.
|
|
Grip Strength
|
28.6 kilogram
STANDARD_DEVIATION 4.1 • n=10 Participants
|
24.5 kilogram
STANDARD_DEVIATION 8.9 • n=11 Participants
|
28.4 kilogram
STANDARD_DEVIATION 8.9 • n=10 Participants
|
26.8 kilogram
STANDARD_DEVIATION 9.1 • n=11 Participants
|
27.0 kilogram
STANDARD_DEVIATION 7.9 • n=42 Participants
|
|
Six Minute Walking Performance
|
446 meter
STANDARD_DEVIATION 90 • n=10 Participants • One Participant opted out of completing this task.
|
393 meter
STANDARD_DEVIATION 96 • n=9 Participants • One Participant opted out of completing this task.
|
377 meter
STANDARD_DEVIATION 129 • n=10 Participants • One Participant opted out of completing this task.
|
441 meter
STANDARD_DEVIATION 71 • n=11 Participants • One Participant opted out of completing this task.
|
416 meter
STANDARD_DEVIATION 99 • n=40 Participants • One Participant opted out of completing this task.
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Professional Led Without Online Support
n=11 Participants
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
|
Professional Led With Online Support
n=10 Participants
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.
|
Patient Empowered With Online Support
n=10 Participants
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
|
Patient Empowered Without Online Support
n=11 Participants
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.
|
|---|---|---|---|---|
|
Pilot Evaluation - Percentage of Participants Retained at Follow up
|
10 Participants
|
10 Participants
|
9 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Incomplete questionnaires were present and excluded from analysis.
Scored with the total score ( range of 14-70), and higher scores reflecting better well-being.
Outcome measures
| Measure |
Professional Led Without Online Support
n=8 Participants
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
|
Professional Led With Online Support
n=9 Participants
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.
|
Patient Empowered With Online Support
n=9 Participants
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
|
Patient Empowered Without Online Support
n=10 Participants
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.
|
|---|---|---|---|---|
|
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
|
54 score on a scale
Standard Deviation 8
|
55 score on a scale
Standard Deviation 7
|
53 score on a scale
Standard Deviation 7
|
50 score on a scale
Standard Deviation 11
|
PRIMARY outcome
Timeframe: 3 monthsConsists 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..
Outcome measures
| Measure |
Professional Led Without Online Support
n=10 Participants
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
|
Professional Led With Online Support
n=10 Participants
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.
|
Patient Empowered With Online Support
n=9 Participants
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
|
Patient Empowered Without Online Support
n=11 Participants
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.
|
|---|---|---|---|---|
|
Short Physical Performance Battery
|
10.3 score on a scale
Standard Deviation 2.5
|
11.4 score on a scale
Standard Deviation 1.0
|
10.4 score on a scale
Standard Deviation 3.0
|
11.1 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Incomplete questionnaires were present and excluded from 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
Outcome measures
| Measure |
Professional Led Without Online Support
n=8 Participants
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
|
Professional Led With Online Support
n=10 Participants
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.
|
Patient Empowered With Online Support
n=7 Participants
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
|
Patient Empowered Without Online Support
n=10 Participants
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.
|
|---|---|---|---|---|
|
SNAQ -Dietary Analysis
|
15.6 units on a scale
Standard Deviation 2.3
|
16 units on a scale
Standard Deviation 2.1
|
17.4 units on a scale
Standard Deviation 1.1
|
16.4 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 3 monthsThe ability to get up from a chair, walk three meters to turn around a cone, and return to sit down again.
Outcome measures
| Measure |
Professional Led Without Online Support
n=10 Participants
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
|
Professional Led With Online Support
n=10 Participants
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.
|
Patient Empowered With Online Support
n=9 Participants
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
|
Patient Empowered Without Online Support
n=11 Participants
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.
|
|---|---|---|---|---|
|
Timed-up-and go
|
10.55 seconds
Standard Deviation 7.04
|
7.11 seconds
Standard Deviation 1.56
|
10.00 seconds
Standard Deviation 9.31
|
8.46 seconds
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Incomplete questionnaires were present and excluded from analysis.
the Quality of Life Short Form -36. Scored with the total score (0-100), and higher scores reflecting better quality of life.
Outcome measures
| Measure |
Professional Led Without Online Support
n=8 Participants
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
|
Professional Led With Online Support
n=9 Participants
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.
|
Patient Empowered With Online Support
n=7 Participants
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
|
Patient Empowered Without Online Support
n=9 Participants
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.
|
|---|---|---|---|---|
|
Quality of Life SF36
|
69 units on a scale
Standard Deviation 19
|
72 units on a scale
Standard Deviation 21
|
64 units on a scale
Standard Deviation 18
|
60 units on a scale
Standard Deviation 19
|
SECONDARY outcome
Timeframe: 3 monthsMeasured with a hand held grip dynamometer. Measured in kilograms, with higher values reflecting higher strength
Outcome measures
| Measure |
Professional Led Without Online Support
n=10 Participants
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
|
Professional Led With Online Support
n=10 Participants
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.
|
Patient Empowered With Online Support
n=9 Participants
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
|
Patient Empowered Without Online Support
n=11 Participants
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.
|
|---|---|---|---|---|
|
Grip Strength
|
24.7 kilogram
Standard Deviation 7.6
|
30.0 kilogram
Standard Deviation 3.7
|
28.0 kilogram
Standard Deviation 9.4
|
27.4 kilogram
Standard Deviation 8.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Some participants opted out of completing the task
Quantifies the distance able to walk during six minutes
Outcome measures
| Measure |
Professional Led Without Online Support
n=9 Participants
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
|
Professional Led With Online Support
n=10 Participants
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.
|
Patient Empowered With Online Support
n=9 Participants
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
|
Patient Empowered Without Online Support
n=10 Participants
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.
|
|---|---|---|---|---|
|
Six Minute Walking Performance
|
396 meter
Standard Deviation 102
|
480 meter
Standard Deviation 89
|
407 meter
Standard Deviation 163
|
439 meter
Standard Deviation 102
|
Adverse Events
Professional Led With Online Support
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Professional Led Without Online Support
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Patient Empowered With Online Support
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Patient Empowered Without Online Support
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Professional Led With Online Support
n=10 participants at risk
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.
|
Professional Led Without Online Support
n=11 participants at risk
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
|
Patient Empowered With Online Support
n=10 participants at risk
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
|
Patient Empowered Without Online Support
n=11 participants at risk
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.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hernia operation and complications
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
9.1%
1/11 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/11 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
|
General disorders
Progressed into disability and housebound
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
9.1%
1/11 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/11 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
|
Gastrointestinal disorders
Sepsis and bowel abscess
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/11 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
9.1%
1/11 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
|
Musculoskeletal and connective tissue disorders
Hip replacement surgery
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
9.1%
1/11 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/11 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
|
Psychiatric disorders
Mental ill-health: stress
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/11 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
9.1%
1/11 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/11 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
9.1%
1/11 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
Other adverse events
| Measure |
Professional Led With Online Support
n=10 participants at risk
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.
|
Professional Led Without Online Support
n=11 participants at risk
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
|
Patient Empowered With Online Support
n=10 participants at risk
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
|
Patient Empowered Without Online Support
n=11 participants at risk
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.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain
|
10.0%
1/10 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
9.1%
1/11 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
18.2%
2/11 • Number of events 2 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
|
General disorders
Fall
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
9.1%
1/11 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/11 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
|
Musculoskeletal and connective tissue disorders
Muscle Injury
|
0.00%
0/10 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
9.1%
1/11 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
10.0%
1/10 • Number of events 1 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
0.00%
0/11 • Three months, the duration of the intervention and the time between baseline and follow up assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place