Evaluation of Reach, Effects and Cost Effectiveness of a Fall Preventive Intervention Including a mHealth Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Reach
研究概览
简要总结
The purpose is to evaluate reach, effects and costs effectiveness of a mobile, fall prevention exercise program for older community-dwelling persons (70+ years) in a pragmatic trial.
Information about the study will be spread to the population by letters sent to all households with someone aged 70 years or older, presentations for senior organizations, advertisements on busses, health care centers, senior centers and in social media. Participants will be recruited in one municipality through the website (www.ostersund.se/sakrasteg) including information about the aim and procedures of the study. If seniors themselves judge that they are eligible to participate in the study, they can register by providing their email address. After baseline assessment, through self-reports in a digital survey, participants will get access to the mobile health application. The estimated target group is 2600 persons. Recruitment will be ongoing for six months. The intervention is delivered through the Safe Step application, developed in co-creation with seniors and researchers. Safe Step provides a large repository of evidence-based balance and strength exercises in video formats alongside falls preventive information and advice. With the Safe Step app the user can compose an individualized exercise program suitable for their needs. To help the user adhere to the program a set of behaviour change techniques is provided by the program. The user can set their own goals, get reminders and positive feedback form a virtual physiotherapist, and follow their own progress. Advice on how to integrate the exercises into everyday activities is also offered. The participants will exercise on their own with the help of the application for one year, with a recommendation of 30 minutes at least 3 times/week. In addition, participants will get monthly emails with falls preventive information in short videos, they will also be asked to report any falls by responding to a survey attached to the message.
In order to maximize reach and to support participants to get started using the Safe Step application, technical support and group-based exercise will be provided.
The interventions will last for 1 year with follow up assessments at 3, 6, 9, and 12 months in addition to the monthly fall reports. Effects and cost effectiveness will be evaluated in relation to a previously registered RCT NCT03963570.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Information on the numbers reached will not be masked. All health outcomes are self-reports and self-assessments by the participants and reported in digital surveys. Outcomes will not be influenced by any other outcome assessors.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years or older
- •Have fallen or experienced a decline in perceived postural balance during the last year
- •Have access to a smartphone or a tablet and uses it regularly
- •Have an own email address and uses it
- •Ability to understand verbal and written instructions in Swedish
- •Can rise from a standard height chair without a person helping
- •Independently mobile without a walking aid indoors
排除标准
- •Progressive disease where there is likely to be a decline in strength or balance over the next year
- •Perceived memory dysfunction that affect everyday life activities
- •Taking part in more than 3 hours each week of strenuous physical exercise which makes them out of breath (e.g. dance, gymnastics, gym exercises, running or skiing)
结局指标
主要结局
Reach
时间窗: 12 months
The number of participants in relation to estimated size of total target population
次要结局
- Rate of attrition(12 months)
- Self-rated balance(Change; Baseline, 3 months, 6 months, 9 months, 12 months)
- Falls efficacy(Change; Baseline, 3 months, 6 months, 9 months, 12 months)
- Use of the information videos(3 months, 6 months, 9 months, 12 months)
- Sociodemographic characteristics age(Baseline)
- Self-rated leg-strength(Change; Baseline, 3 months, 6 months, 9 months, 12 months)
- Participation in technical support sessions(12 months)
- Participation in try-out group exercises(12 months)
- Health related quality of life(Change; Baseline, 3 months, 6 months, 9 months, 12 months)
- Exercise adherence throughout the intervention(12 months)
- Sociodemographic characteristics gender(Baseline)
- Sociodemographic characteristics living conditions(Baseline)
- Perceived Exertion(Change; Baseline, 3 months, 6 months, 9 months, 12 months)
- Self-rated improvements in leg-strength(12 months)
- Costs related to the interventions(12 months)
- Functional leg strength([Time Frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months])
- Experienced negative effects of the exercise intervention(3 months, 6 months, 9 months, 12 months)
- Physical activity(Change: Baseline, 12 months)
- Cost-effectiveness(12 months)
- Experienced positive effects of the exercise intervention(3 months, 6 months, 9 months, 12 months)
- Self-rated improvements in balance(12 months)
- New exercise routines(12 months)
- Fall rate(12 months)
- Number of fallers(12 months)