Clinical trial NCT05384730: Frail2Fit Study: Online Nutrition and Exercise Support for Older Adults With Frailty
Official title: A Feasibility and Acceptability Study of a Virtual Multimodal Intervention Delivered by Volunteers to Improve Functional Outcomes of Frail Older Adults Discharged From Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Malnutrition
Sedentary Behavior
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Bournemouth University
name: University of Southampton
First posted: 2022-05-20
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Frail2Fit will explore the feasibility of training volunteers to deliver online nutrition, exercise, and behaviour change (supported self-management) to improve the health of older people after discharge from hospital. The study also aims to explore if the supported self-management is acceptable to older people, their family members and/or carers, and the volunteers.

Between 30-60% of older people in hospital lose muscle strength and function (deconditioning) and around 14% of older adults in hospital are frail. Reduced muscle function and frailty increase risk of poor health outcomes, including reduced quality of life, increased risk of hospital readmission and increased risk of mortality. Therefore, intervening to prevent functional decline is a high-priority patient-centred outcome. Current evidence suggest that physical activity (PA) and nutrition interventions are key to maintaining independence and improving frailty status. In response to the COVID-19 restrictions, healthcare and rehabilitation have increasingly turned to virtual modes of delivery, such as telehealth methods. The increasing use of technology in the daily lives of many allows PA and nutrition interventions to be delivered online. For instance, the investigators have developed and evaluated a programme using online clinics to successfully support over 600 cancer patients living at home to stay active and eat well with provision of emotional support (SafeFit study). With many older people now using the internet for social connection, the team have an opportunity to investigate whether a similar model can improve the health of older people.

This study aims to explore the feasibility and acceptability of implementing volunteer-led online exercise and nutrition support to frail older people discharged from hospital. The investigators aim to develop and evaluate a training programme for volunteers, determine the acceptability of the intervention through qualitative methods and identify facilitators and barriers to its implementation. The investigators will also explore the impact of the intervention on health outcomes for older people to inform future trial.

Detailed description: Study design A quasi-experimental mixed methods approach will be used to determine the feasibility and acceptability of implementing a volunteer-led multi-modal intervention for discharged older adults with frailty. This feasibility study will be conducted at the University Hospital Southampton NHS Foundation Trust (UHS), training hospital volunteers to deliver virtual group support for older adults discharged from UHS. The acceptability of the intervention will also be examined through qualitative interviews to explore the views and experiences of volunteers, trainers, carers and older adults involved in this study. The impact of the intervention on physical activity levels and functional outcomes will be measured.

Participants Older adults aged 65 years or above with frailty (clinical frailty score ≥5) who have been discharged from UHS will be invited to participate in this study. Participants must be able to walk at least a few steps upon hospital discharge and be cleared by their clinician as safe to exercise. Patients will be identified and approached by their clinical care team, if they are interested in participating in the research a member of the research team will obtain written informed consent. A sample size of 30 participants was chosen in line with previous sample size recommendations for feasibility studies of 24-50 participants. This sample size was considered an appropriate number that is pragmatic and achievable within the study timescale and resources available.

Recruitment and training of volunteers Volunteers from the UHS patient support hub will be invited to participate in the study and receive training to deliver the intervention. Volunteers aged 16 years or above who have completed the generic volunteer clearance and training at the hospital and who are safe to exercise will be identified by hospital voluntary services. Interested volunteers will be approached by a member of the research team to complete written informed consent. A sample size of 6 volunteers was chosen to provide sufficient cover to deliver the Frail2Fit intervention to small groups of older adults with 2 volunteers supporting each group.

The volunteer training programme will consist of a bespoke training package adapted from the SafeFit training guidance, supported, and delivered by an expert dietician (Prof Jane Murphy), psychologist (Judit Varkonyi-Sepp), and clinical exercise instructor, Dr Samantha Meredith (SM), and led by the PI, Dr Stephen Lim (SL). Training will be conducted at UHS for 2 days and 1 day of online training. The training sessions will include training on personal safety and safety of participants, and the exercise, nutrition and behaviour change protocols. As these are existing volunteers, they would have been recruited, and received the generic clearance and training provided by UHS. Throughout the study period, fidelity checks will be conducted by SM and SL to ensure that the volunteers are delivering high quality exercise sessions. Volunteers will also receive training on how to document adverse events that occur during the classes.

Intervention The intervention duration will be 3 months. Participants will receive three group sessions per week for 1 month (weeks 1-4), twice per week for the second month (weeks 5-8), and once weekly for the last month (weeks 9-12), with a maximum of 24 sessions. The tapered nature of the intervention was chosen to provide suitable support for older adults post-discharge with the aim to gradually encourage increased self-management to foster independence post-intervention. Components of the intervention, including exercise, nutrition support and behaviour change support, will be delivered from an online platform (Zoom). Each group session will last 40-60 minutes, including 20-30 minutes of exercise followed by 20-30 minutes of nutrition support. The components of the intervention and the training package have been adapted from the SafeFit trial and will be delivered in line with behaviour change principles to maximise participant uptake, adherence and lifestyle self-management.

The exercise will consist of volunteer-led group progressive resistance exercise training for 20-30 minutes. To align with home-based safety considerations, the exercises will be performed seated. Seated exercise will focus on strengthening upper and lower limbs (8 major muscle groups) and enhancing whole body range of motion and flexibility, tailored specifically to meet the needs of older adults and to minimise the risks of injury.

The nutrition component will involve reviewing patient diet and eating habits using the Nutrition Wheel to ensure nutrition is appropriate and patients are not at risk of undernutrition. The Nutrition Wheel is an interactive tool developed from the Patients Association Nutrition Checklist and used to engage individuals in conversation about unintentional weight loss and malnutrition.

Healthy conversation skills (HCS) guided by principles of Making Every Contact Count (MECC) will be used to support the delivery of the exercise and nutrition components in the current intervention. The MECC approach supports positive behaviour change through encouraging client-centred brief conversations surrounding health and well-being. Training will enable volunteers to have the confidence and competence to deliver healthy lifestyle messages to empower participants.

Data collection Participant characteristics including age, gender, domicile status, weight, body mass index, malnutrition status (MUST), baseline nutritional status (e.g., use of nutritional supplements and dietician support), co-morbidities (Charlson Co-morbidity Index), cognition (Mini-mental state examination; MMSE) and number of medications will be recorded. Volunteer characteristics recorded will include age, occupation, qualifications, volunteering experience, and employment status.

The primary outcome measures are feasibility and acceptability of the intervention. The feasibility of implementing a volunteer-led online multi-modal intervention will be assessed by determining the number of volunteers recruited, trained and retained at the end of the study, the number of intervention sessions delivered and fidelity of volunteer delivery. Moreover, participant recruitment, retention and adherence to the intervention will be measured, as well as any adverse events. Interviews will be conducted among older adults (N= 6), volunteers (N= 6), and those involved in recruiting participants and training volunteers (N= 3), to determine the acceptability of the intervention and to explore barriers and enablers to the implementation of the intervention. Interviews will be semi-structured to help guide conversation whilst allowing participants the flexibility to elaborate and reflect on any meaningful experiences.

The secondary outcomes will include the measurement of physical activity levels (PASE and GENE Activ accelerometer), physical function (Bathel), appetite (SNAQ), well-being (WEMWBS), anxiety and depression (HADS), quality of life (EQ-5D-5L ), and self-efficacy for managing chronic disease. These will be measured at baseline (in hospital), 3 months (via telephone) and 6 months (via telephone).

Data analysis Quantitative data analysis Data collected will be double entered into a secured database for analysis. Statistical analysis will be conducted using the statistical software SPSS. Descriptive statistics -median (IQR); mean (SD); number (%) - will be used to analyse the numbers of volunteers recruited, trained and retained, as well as the type and extent of progression of the resistance exercise, and duration of their activity, and patients' adherence to the intervention. Analysis of the above outcome measures will be used to develop an assessment of the feasibility of delivering this intervention. To determine suitability for a future, fully-powered effectiveness study of the intervention, outcome measures recorded at baseline will be compared to measurement at 3 and 6 months to determine if the intervention had an impact on physical activity levels measured by PASE and GENEActiv, functional outcomes including Barthel, SNAQ, HADS, WENWBS, self-efficacy and EQ-5D-5L. The distribution of each outcome measure will be assessed for normality and described using parametric or non-parametric statistics accordingly. A basic cost-analysis of the training programme will be carried out, costing the time of clinical staff involved in delivering the training.

Qualitative data analysis Data collected from the interviews will be transcribed verbatim and analysed using thematic analysis (TA). The audio-recordings will be transcribed by an administrative colleague within the research department who is experienced in transcribing qualitative data. TA is a method for identifying, analysing and reporting patterns or themes within data and is widely used in qualitative research. There are six phases in the process of conducting TA: Phase 1 - familiarising with the data, Phase 2 - generating initial codes, Phase 3 - searching for themes, Phase 4 - reviewing themes, Phase 5 - defining and naming themes, and Phase 6 - producing the report. Analysis of qualitative data will be conducted using either Microsoft Word, or with the help of NVIVO, depending on the amount of data collected. Transcribed text will be read and coded separately and then together by two researchers. The codes will be analysed to generate concepts and ideas to determine the acceptability of the intervention, and to identify facilitators and barriers to the implementation process. The codes act as tags or labels to help catalogue key concepts embedded within the raw data. From the codes, themes will be developed to reflect the views and experiences of the community-dwelling older adults and volunteers regarding the community-based PA intervention.

Eligibility criteria: Inclusion Criteria:

Patients:

* Older adults age 65 years and above
* Able to provide written consent
* Discharged from UHS
* Identified as frail (Clinical Frailty Scale ≥5)
* Able to walk at least a few steps upon hospital discharge
* Able to communicate fluently enough in English

Volunteers:

* Established volunteers at UHS patient support hub
* Age 16 years and above
* Completed the generic volunteer clearance and training at UHS
* Able to provide written informed consent
* Able to communicate fluently enough in English

Exclusion Criteria:

Patients:

* Older adults who are not able to safely complete the exercises included in the intervention
* Patients who are discharged to rehabilitation units, or care homes
* Patients receiving end of life care

Volunteers:

- Volunteers who are unable to safely complete the exercises included in the intervention will be excluded from the study

Primary outcomes:
measure: Volunteers Trained
timeFrame: 6 months
measure: Volunteer Retention
timeFrame: 6 months
measure: Adherence - Online
timeFrame: post-intervention = 3-months
measure: Adherence - Telephone Support
timeFrame: post-intervention= 3-months
Secondary outcomes:
measure: Device-based Physical Activity Levels
timeFrame: Baseline, post-intervention (3-months) and follow-up (6-months)
measure: Functional Ability
timeFrame: Baseline, post-intervention (3-months) and follow-up (6-months)
measure: Appetite
timeFrame: Baseline, Post-intervention (3-month) and follow-up (6-month)
measure: Well-being
timeFrame: Baseline, Post-intervention (3-month) and follow-up (6-month)
measure: Depression and Anxiety
timeFrame: Baseline, post-intervention (3-month) and follow-up (6-month)
measure: Patient's Subjective Assessment of Quality of Life
timeFrame: Baseline, Post-intervention (3-month) and follow-up (6-month)
measure: Self-efficacy for Managing Chronic Disease
timeFrame: Baseline, Post-intervention (3-month) and follow-up (6-month)
measure: Self-reported Physical Activity
timeFrame: Baseline, Post-Intervention (3-month), Follow-Up (6-months)
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Stephen ER Lim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grimmett C, Bates A, West M, Leggett S, Varkonyi-Sepp J, Campbell A, Davis J, Wootton S, Shaw C, Barlow R, Ashcroft J, Scott A, Moyes H, Hawkins L, Levett DZH, Williams F, Grocott MPW, Jack S. SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial. BMJ Open. 2021 Aug 26;11(8):e048175. doi: 10.1136/bmjopen-2020-048175.
citation: Lim SER, Meredith S, Agnew S, Clift E, Ibrahim K, Roberts H. Evaluating the feasibility and acceptability of virtual group exercise for older adults delivered by trained volunteers: the ImPACt study protocol. BMJ Open. 2022 Feb 1;12(2):e052631. doi: 10.1136/bmjopen-2021-052631.
citation: Meredith SJ, Roberts H, Grocott MPW, Jack S, Murphy J, Varkonyi-Sepp J, Bates A, Lim SER. Frail2Fit study protocol: a feasibility and acceptability study of a virtual multimodal intervention delivered by volunteers to improve functional outcomes in older adults with frailty after discharge from hospital. BMJ Open. 2023 Mar 16;13(3):e069533. doi: 10.1136/bmjopen-2022-069533.