Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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 |
12 weeks |
|
| Primary |
Recruitment rates |
Cumulative recruitment against target rate each month |
6 months |
|
| Primary |
Retention rates |
Calculated as the number of participants who completed the study divided by the number of participants randomised |
12 weeks |
|
| Primary |
Acceptability of the intervention and study design |
This will be assessed qualitatively through semi-structured one-to-one interviews with a subset of participants |
12-16 weeks |
|
| Primary |
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 |
12 weeks |
|
| Primary |
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. |
12 weeks |
|
| Secondary |
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. |
Baseline, 12 weeks |
|
| Secondary |
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. |
Baseline, 12 weeks |
|
| Secondary |
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. |
Baseline, 12 weeks |
|
| Secondary |
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. |
Baseline, 12 weeks |
|
| Secondary |
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 |
Baseline, 12 weeks |
|
| Secondary |
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. |
Baseline, 12 weeks |
|
| Secondary |
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 |
Baseline, 12 weeks |
|
| Secondary |
Change in BMI |
Body weight [kg] and height [m] to calculate body mass index (BMI) |
Baseline, 12 weeks |
|
| Secondary |
Participants socio-demographic characteristics |
Age, gender, marital status, occupation, education, income, ethnicity, smoking status, use of digital technology, shopping and cooking habits. |
Baseline |
|
| Secondary |
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. |
Baseline, 12 weeks |
|
| Secondary |
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. |
Baseline, 12 weeks |
|
| Secondary |
Adverse events |
Number of adverse events that occurred as a result of participation in the study |
From recruitment until study end (approximately 14 weeks) |
|
