Evaluation of Reach, Effects & Cost Effectiveness of a Fall Preventive

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Accidental Falls

Clinical Trial Details

NCT number	NCT04161625
Study type	Interventional
Source	Umeå University
Contact
Status	Completed
Phase	N/A
Start date	October 14, 2019
Completion date	April 13, 2021

View Details

See also
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Completed	`NCT00365430` - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes	N/A
Completed	`NCT00226486` - Examination and Treatment of Elderly After a Fall	N/A
Active, not recruiting	`NCT00222287` - The Effect of Feldenkrais Lessons on Walking and Balance	Phase 1
Recruiting	`NCT03731572` - Hip Muscle Power, Lateral Balance Function, and Falls in Aging	N/A
Recruiting	`NCT05625828` - Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program on Fall Risk Factors	N/A
Recruiting	`NCT05377801` - Chinese Version of LIVE-LiFE for Older Adults With Previous Falls	N/A
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Completed	`NCT02835989` - Community Paramedicine at Home	N/A
Recruiting	`NCT02926105` - Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults	Phase 3
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of Reach, Effects and Cost Effectiveness of a Fall Preventive Intervention Including a mHealth Application

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms