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临床试验/NCT03707145
NCT03707145已完成不适用

Effect of Online Support and Patient Empowerment on Functional Ability and Well-being in Older Adults: a Pilot Study

Aberystwyth University2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年3月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Pilot Evaluation - Percentage of Participants Retained at Follow up

研究概览

简要总结

This study is looking at whether older people could benefit from an online monitoring platform to support their individual ambitions to maintain or improve functional ability. It is hypothesized this will enable the individual 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. All information can be linked back to the health care professional for official support and intervene when a decline is noticed, in order to prevent frailty from developing. The aim of this study is to find out if providing more support and greater empowerment can help older people improve their functional ability by self-monitoring and personalised interventions.

详细描述

Participants will be individually randomised using randomisation service on a 1:1 allocation ratio to either group. There will be 4 groups, with differences in the consultation design and online support available.

Participant assessments consists of questionnaires and physical tasks completed during two visits at the university facilities. During the second visit, a one-hour consultation with a health care professional will take place to develop a twelve-week action plan to promote a healthier lifestyle.

Frailty status will be defined from the Fried frailty phenotype criteria. Exercise status will be based on current physical activity levels and the Short Physical Performance Battery score derived from the chair-stands, gait speed and balance assessments.

Participants in the experimental group will receive the assessment, and the consultation will aim to promote to empower them, plus access to the online support platform, termed 'FACET'.

Participants in the empowerment groups are provided with a structured booklet prior to the consultation to help the participant actively contribute to their own intervention programme, whereas in the other groups,the professional will lead the consultation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The participant is unaware of the other groups details. Assessor and investigator are not blinded due to the need for providing information to the participant about their group allocation in this pilot project

入排标准

年龄范围
60 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 years and over
  • Willingness to give informed consent, to be randomized to one of the study groups, and comply with all study requirements
  • Community dwelling, assisted living conditions or care home residents.
  • Ability to walk 10 m independently, or with support if using a cane or walker.
  • Ability to understand instructions regarding the use of the technology and execution of the exercise program.

排除标准

  • Moderate/severe dementia at baseline (defined as Mini Mental State Examination < 23),
  • Severe, disabling stroke at baseline within the previous 6 months (defined as new or previous stroke with Barthel Index < 9),
  • Recent (< 3 months prior randomisation) myocardial infarction, or unstable angina.
  • Currently undergoing treatment that includes exercise and diet advice by health professionals
  • Referred at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation) within the previous 6 months.
  • Currently taking part in another study or taken part in an intervention study in the previous six months

研究组 & 干预措施

Professional led with online support

Active Comparator

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.

干预措施: Consultation (Behavioral)

Professional led with online support

Active Comparator

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.

干预措施: Online Support (Behavioral)

Professional led without online support

Active Comparator

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.

干预措施: Consultation (Behavioral)

Patient empowered with online support

Experimental

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.

干预措施: Consultation (Behavioral)

Patient empowered with online support

Experimental

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.

干预措施: Online Support (Behavioral)

Patient empowered with online support

Experimental

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.

干预措施: Empowered (Behavioral)

Patient empowered without online support

Active Comparator

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.

干预措施: Consultation (Behavioral)

Patient empowered without online support

Active Comparator

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.

干预措施: Empowered (Behavioral)

结局指标

主要结局

Pilot Evaluation - Percentage of Participants Retained at Follow up

时间窗: 3 Months

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.

Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

时间窗: 3 months

Scored with the total score ( range of 14-70), and higher scores reflecting better well-being.

Short Physical Performance Battery

时间窗: 3 months

Consists 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..

次要结局

  • SNAQ -Dietary Analysis(3 months)
  • Timed-up-and go(3 months)
  • Quality of Life SF36(3 months)
  • Grip Strength(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Arkesteijn

Lecturer in Sport and Exercise Biomechanics

Aberystwyth University

研究点 (2)

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