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Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults

Primary Purpose

Malnutrition, Healthy Aging, Dehydration

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Keep-on-Keep-Up Nutrition (KOKU-Nut)
Sponsored by
Chloe French
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring feasibility, malnutrition, dehydration, digital health

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 65 years or older Living independently in the community Have access to the internet (to complete online dietary assessment) Willing to use an iPad or tablet (their own or one provided) for the duration of the study Exclusion Criteria: Unable to communicate in English Have a known cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    KOKU-Nut

    Usual care

    Arm Description

    Participants will be helped to download KOKU-Nut onto their ipad or tablet during the baseline visit and will receive training. In cases where participants do not have the necessary devices or data to join the intervention, a tablet with KOKU-Nut installed will be provided for the duration of the intervention. Participants will be asked to engage with KOKU-Nut at least 3 times a week throughout the 12-week period.

    Participants will continue with usual care and will receive a leaflet developed by Age UK about the importance of a healthy lifestyle including information on the importance of staying active and nutrition.

    Outcomes

    Primary Outcome Measures

    Self-reported use of KOKU
    Participants asked about their engagement with KOKU as part of the follow up case report. Participants respond with the option that suits their use best from the following options: every day; 3-4 times a week; 1-2 times a week; once or twice a month
    Recruitment rates
    Cumulative recruitment against target rate each month
    Retention rates
    Calculated as the number of participants who completed the study divided by the number of participants randomised
    Acceptability of the intervention and study design
    This will be assessed qualitatively through semi-structured one-to-one interviews with a subset of participants
    Acceptability of the intervention
    A questionnaire developed by the research team along with the 11-item, 7-point modified treatment evaluation inventory. Higher scores indicate higher acceptability, with a score of 44 indicating moderate acceptability
    Usability of the intervention
    Participants in intervention group will complete the 10-item system usability scale (SUS) to assess perceived usability of the intervention. Responses are measured on a 5-point Likert scale ranging from one (strongly disagree) to five (strongly agree). A score >68 is considered above average usability and >80 is considered high usability.

    Secondary Outcome Measures

    Change in dietary intake
    Intake of food groups will be generated from a 3-day food diary inputted onto Intake24 software to identify adherence to the Eatwell guide.
    Risk of malnutrition
    The malnutrition universal screening tool (MUST) will also be used to assess risk of malnutrition based on BMI, unplanned weight loss and acute disease effect. For each component participants receive a score between 0-2 and cumulative scores are calculated (which can range from 0-6) such that 0 indicates low risk, 1 indicates medium risk and a score of 2 or more indicates a high risk of malnutrition.
    Risk of malnutrition
    The Global Leadership Initiative on Malnutrition (GLIM) diagnostic criteria will also be used to assess risk of malnutrition. Participants are assessed on 3 phenotypic criteria (non-volitional weight loss, low body mass index, and reduced muscle mass) and 2 etiologic criteria (reduced food intake or assimilation, and inflammation of disease burden). To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present.
    Change in physical function
    Participants will be instructed to rise from a chair 5 times as quickly as possible with arms folded across their chest and the researcher will record the time taken to complete the task. The researcher will then calculate lower limb muscle power using a validated equation.
    Change in physical function
    Grip strength (kg) will be assessed on a Jamar hydraulic dynamometer three times on each hand with the best score used for analysis
    Change in health related quality of life
    The EuroQol visual analogue scale (EQ-VAS) will be used for participants to describe their perceived state of health. The score can range from 0 (lowest level of health) to 100 (best health imaginable) where participants indicate how they perceive their current health status both on a number line and numerically.
    Change in health related quality of life
    The participants perceived state of health and quality of life will be assessed using the validated EuroQol- 5 Dimension (EQ-5D-5L). The EQ-5D-5Lcomprises five questions assessing mobility, self-care, usual activities, pain or discomfort and anxiety or depression to produce an overall score representing the participant's health profile. The score ranges from one (full health) to zero (state of health equitable to death) with the option to have negative values that indicates a state of health considered to be worse than death
    Change in BMI
    Body weight [kg] and height [m] to calculate body mass index (BMI)
    Participants socio-demographic characteristics
    Age, gender, marital status, occupation, education, income, ethnicity, smoking status, use of digital technology, shopping and cooking habits.
    Change in mood
    Participants will complete the 4-item Geriatric depression scale as part of the baseline and follow-up questionnaire. A cumulative scores of 0 indicates participant is not depressed, a score of 1 shows uncertainty and a score between 2 and 4 (inclusive) indicates the participant is depressed.
    Change in frailty status
    Researcher will assess frailty of participants based on descriptions and images included in the clinical frailty scale. Scores range from 1 (very fit) to 9 (terminally ill) and a score 5 or more indicates frailty.
    Adverse events
    Number of adverse events that occurred as a result of participation in the study

    Full Information

    First Posted
    May 31, 2023
    Last Updated
    July 4, 2023
    Sponsor
    Chloe French
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05943366
    Brief Title
    Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults
    Official Title
    Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults: a Mixed-methods Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Chloe French

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Trial Design: This is a feasibility randomised controlled trial. Aim: The study aims to assess the feasibility of conducting a randomised controlled trial using a digital health tool (Keep-On-Keep-Up Nutrition, KOKU-Nut) to improve dietary intake in community-dwelling older adults. Objectives: Is it feasible and practical to run KOKU-Nut study as a powered randomised controlled trial. Adherence to the intervention, motivations, barriers and facilitators of engaging with KOKU-Nut Study population: Community-dwelling adults aged 65 and older Intervention: Participants in the intervention group will be asked to engage with KOKU-Nut at least 3 times a week throughout the 12-week period. A crib sheet and contact details for the research team will be available if participants require additional support to help with technical issues. Control: Participants will continue with usual care and receive a leaflet developed by Age UK about the importance of a healthy lifestyle. Timing and duration 3 month intervention with interviews carried out approximately one week after the intervention period
    Detailed Description
    Background: Dietary patterns can play an important role in health in older age. Apps that encourage dietary change are available and commonly used in younger populations, however; few are designed for the nutritional and technical requirements of older adults. Keep-On-Keep-Up Nutrition (KOKU-Nut) is the latest development of the digital tool and includes nutritional games based on the Eatwell guide to nudge older adults to improve their diet with a specific focus on protein, fibre and fluid. The innovation process has brought together researchers, clinicians, software designers and older users to co-develop the digital tool. In this study, researchers will test the practicality of KOKU-Nut as an intervention before further larger studies are conducted to assess it's effectiveness. The aim of this study is to assess the feasibility of conducting a randomised controlled trial using this digital health tool (KOKU-Nut) to improve dietary intake in community-dwelling older adults. Participants will be randomised to receive usual care and an information booklet about living a healthy lifestyle or to the intervention group and asked to engage with KOKU-Nut 3 times a week for 12 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition, Healthy Aging, Dehydration
    Keywords
    feasibility, malnutrition, dehydration, digital health

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prior to completing baseline measures, participants will be randomised in a 1:1 ratio to receive the intervention (KOKU-Nut) or to the control group and receive usual care. Randomisation will be undertaken by a separate member of the research team using the Sealed Envelope randomisation service.
    Masking
    None (Open Label)
    Masking Description
    Given the nature of the intervention, participants and researchers will be unblinded.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    KOKU-Nut
    Arm Type
    Experimental
    Arm Description
    Participants will be helped to download KOKU-Nut onto their ipad or tablet during the baseline visit and will receive training. In cases where participants do not have the necessary devices or data to join the intervention, a tablet with KOKU-Nut installed will be provided for the duration of the intervention. Participants will be asked to engage with KOKU-Nut at least 3 times a week throughout the 12-week period.
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    Participants will continue with usual care and will receive a leaflet developed by Age UK about the importance of a healthy lifestyle including information on the importance of staying active and nutrition.
    Intervention Type
    Device
    Intervention Name(s)
    Keep-on-Keep-Up Nutrition (KOKU-Nut)
    Intervention Description
    Keep-on-Keep-Up (KOKU) is a free, tablet-based strength and balance exercise application that was soft launched in 2020 (https://kokuhealth.com/). KOKU is approved by the National Health Service (NHS) and Organisation for the Review of Care and Health Apps (ORCHA) as a lifestyle app and has been viewed positively by older adults after 6 weeks of independent use. KOKU-Nut is the latest development of this interactive platform and includes nutritional games based on the UK dietary guidelines to nudge older adults to improve their diet with a specific focus on protein, fibre and fluid.
    Primary Outcome Measure Information:
    Title
    Self-reported use of KOKU
    Description
    Participants asked about their engagement with KOKU as part of the follow up case report. Participants respond with the option that suits their use best from the following options: every day; 3-4 times a week; 1-2 times a week; once or twice a month
    Time Frame
    12 weeks
    Title
    Recruitment rates
    Description
    Cumulative recruitment against target rate each month
    Time Frame
    6 months
    Title
    Retention rates
    Description
    Calculated as the number of participants who completed the study divided by the number of participants randomised
    Time Frame
    12 weeks
    Title
    Acceptability of the intervention and study design
    Description
    This will be assessed qualitatively through semi-structured one-to-one interviews with a subset of participants
    Time Frame
    12-16 weeks
    Title
    Acceptability of the intervention
    Description
    A questionnaire developed by the research team along with the 11-item, 7-point modified treatment evaluation inventory. Higher scores indicate higher acceptability, with a score of 44 indicating moderate acceptability
    Time Frame
    12 weeks
    Title
    Usability of the intervention
    Description
    Participants in intervention group will complete the 10-item system usability scale (SUS) to assess perceived usability of the intervention. Responses are measured on a 5-point Likert scale ranging from one (strongly disagree) to five (strongly agree). A score >68 is considered above average usability and >80 is considered high usability.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Change in dietary intake
    Description
    Intake of food groups will be generated from a 3-day food diary inputted onto Intake24 software to identify adherence to the Eatwell guide.
    Time Frame
    Baseline, 12 weeks
    Title
    Risk of malnutrition
    Description
    The malnutrition universal screening tool (MUST) will also be used to assess risk of malnutrition based on BMI, unplanned weight loss and acute disease effect. For each component participants receive a score between 0-2 and cumulative scores are calculated (which can range from 0-6) such that 0 indicates low risk, 1 indicates medium risk and a score of 2 or more indicates a high risk of malnutrition.
    Time Frame
    Baseline, 12 weeks
    Title
    Risk of malnutrition
    Description
    The Global Leadership Initiative on Malnutrition (GLIM) diagnostic criteria will also be used to assess risk of malnutrition. Participants are assessed on 3 phenotypic criteria (non-volitional weight loss, low body mass index, and reduced muscle mass) and 2 etiologic criteria (reduced food intake or assimilation, and inflammation of disease burden). To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present.
    Time Frame
    Baseline, 12 weeks
    Title
    Change in physical function
    Description
    Participants will be instructed to rise from a chair 5 times as quickly as possible with arms folded across their chest and the researcher will record the time taken to complete the task. The researcher will then calculate lower limb muscle power using a validated equation.
    Time Frame
    Baseline, 12 weeks
    Title
    Change in physical function
    Description
    Grip strength (kg) will be assessed on a Jamar hydraulic dynamometer three times on each hand with the best score used for analysis
    Time Frame
    Baseline, 12 weeks
    Title
    Change in health related quality of life
    Description
    The EuroQol visual analogue scale (EQ-VAS) will be used for participants to describe their perceived state of health. The score can range from 0 (lowest level of health) to 100 (best health imaginable) where participants indicate how they perceive their current health status both on a number line and numerically.
    Time Frame
    Baseline, 12 weeks
    Title
    Change in health related quality of life
    Description
    The participants perceived state of health and quality of life will be assessed using the validated EuroQol- 5 Dimension (EQ-5D-5L). The EQ-5D-5Lcomprises five questions assessing mobility, self-care, usual activities, pain or discomfort and anxiety or depression to produce an overall score representing the participant's health profile. The score ranges from one (full health) to zero (state of health equitable to death) with the option to have negative values that indicates a state of health considered to be worse than death
    Time Frame
    Baseline, 12 weeks
    Title
    Change in BMI
    Description
    Body weight [kg] and height [m] to calculate body mass index (BMI)
    Time Frame
    Baseline, 12 weeks
    Title
    Participants socio-demographic characteristics
    Description
    Age, gender, marital status, occupation, education, income, ethnicity, smoking status, use of digital technology, shopping and cooking habits.
    Time Frame
    Baseline
    Title
    Change in mood
    Description
    Participants will complete the 4-item Geriatric depression scale as part of the baseline and follow-up questionnaire. A cumulative scores of 0 indicates participant is not depressed, a score of 1 shows uncertainty and a score between 2 and 4 (inclusive) indicates the participant is depressed.
    Time Frame
    Baseline, 12 weeks
    Title
    Change in frailty status
    Description
    Researcher will assess frailty of participants based on descriptions and images included in the clinical frailty scale. Scores range from 1 (very fit) to 9 (terminally ill) and a score 5 or more indicates frailty.
    Time Frame
    Baseline, 12 weeks
    Title
    Adverse events
    Description
    Number of adverse events that occurred as a result of participation in the study
    Time Frame
    From recruitment until study end (approximately 14 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged 65 years or older Living independently in the community Have access to the internet (to complete online dietary assessment) Willing to use an iPad or tablet (their own or one provided) for the duration of the study Exclusion Criteria: Unable to communicate in English Have a known cognitive impairment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chloe French
    Phone
    07581770599
    Email
    chloe.french@manchester.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sorrel Burden
    Phone
    3067856
    Ext
    0161
    Email
    sorrel.burden@manchester.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emma Stanmore
    Organizational Affiliation
    University of Manchester
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults

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