NCT04161625

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

Completed NA Last updated 29 September 2021

What this trial tests

NA trial testing Digital exercise program with support in Accidental Falls in 173 participants. Completed in 13 April 2021.

Timeline

14 October 2019

Primary endpoint
13 April 2021

13 April 2021

Quick facts

Lead sponsor	Umeå University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	173
Start date	14 October 2019
Primary completion	13 April 2021
Estimated completion	13 April 2021
Sites	1 location across Sweden

Drugs / interventions tested

• Digital exercise program with support

Conditions studied

• Accidental Falls — all drugs for Accidental Falls →

Sponsor

Umeå University

Who can join

70 and older, any sex, with Accidental Falls. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reaching Older People With a Digital Fall Prevention Intervention in a Swedish Municipality Context-an Observational Study.
   Bajraktari S, Zingmark M, Pettersson B, Rosendahl E, et al · · 2022 · cited 11× · PMID 35548075 · DOI 10.3389/fpubh.2022.857652