Exploring the Feasibility of a Digital Service to Improve Nutrition and Hydration Status of Older Adults: a Mixed-methods Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Chloe French
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retention rates
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Given the nature of the intervention, participants and researchers will be unblinded.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Unable to communicate in English
- •Have a known cognitive impairment
结局指标
主要结局
Retention rates
时间窗: 12 weeks
Calculated as the number of participants who completed the study divided by the number of participants randomised
Usability of the intervention
时间窗: 12 weeks
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.
Recruitment rates
时间窗: 6 months
Cumulative recruitment against target rate each month
Self-reported use of KOKU
时间窗: 12 weeks
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
Acceptability of the intervention and study design
时间窗: 12-16 weeks
This will be assessed qualitatively through semi-structured one-to-one interviews with a subset of participants
Acceptability of the intervention
时间窗: 12 weeks
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
次要结局
- Change in dietary intake(Baseline, 12 weeks)
- Change in frailty status(Baseline, 12 weeks)
- Adverse events(From recruitment until study end (approximately 14 weeks))
- Participants socio-demographic characteristics(Baseline)
- Change in BMI(Baseline, 12 weeks)
- Change in mood(Baseline, 12 weeks)
- Risk of malnutrition(Baseline, 12 weeks)
- Change in physical function(Baseline, 12 weeks)
- Change in health related quality of life(Baseline, 12 weeks)
研究者
Chloe French
Principal Investigator
University of Manchester