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

NCT ID: NCT04161625

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2021-04-13

Brief 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.

Conditions

Accidental Falls

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Safe Step - digital exercise program

All included participants will receive full access to the Safe Step application and create their own individual program of strength and balance exercises. During 1 year the participants are recommended to exercise at least 30 minutes, 3 times a week and continuously progress their program. In addition they will every month receive an email with general falls prevention information in a short video.

Additional support to promote reach and exercise adherence will be provided in the format of technical support and try-out group exercises throughout the recruitment period.

Group Type: EXPERIMENTAL

Digital exercise program with support

Intervention Type: BEHAVIORAL

The Safe Step application includes an instruction movie on how to create and progress an individual exercise program. The exercises, presented in video format, are organized into 10 groups with a main focus on balance (3 groups), lower-limb strength (4 groups), and gait/step (3 groups). The participants choose an exercise suitable for their needs from each group to compose a program of ten exercises.

Participants use the app to plan their exercises, set reminders, register their exercise, and view statistics. A virtual physiotherapist delivers motivational messages and feed-back. At the end of each month the participants receive an email asking them to report any falls during the past month in a short digital survey. These messages also contains a new video with general falls prevention information.

Technical support will be provided weekly at senior meeting sites. Try-out group exercises (step 1-3) will be provided by a local wellness association (Friskis&Svettis)

Interventions

Digital exercise program with support

The Safe Step application includes an instruction movie on how to create and progress an individual exercise program. The exercises, presented in video format, are organized into 10 groups with a main focus on balance (3 groups), lower-limb strength (4 groups), and gait/step (3 groups). The participants choose an exercise suitable for their needs from each group to compose a program of ten exercises.

Participants use the app to plan their exercises, set reminders, register their exercise, and view statistics. A virtual physiotherapist delivers motivational messages and feed-back. At the end of each month the participants receive an email asking them to report any falls during the past month in a short digital survey. These messages also contains a new video with general falls prevention information.

Technical support will be provided weekly at senior meeting sites. Try-out group exercises (step 1-3) will be provided by a local wellness association (Friskis&Svettis)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marlene Sandlund, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Umeå universitet

Locations

Caring Science Buildning, Umeå University

Umeå, , Sweden

Countries

Sweden

References

Bajraktari S, Zingmark M, Pettersson B, Rosendahl E, Lundin-Olsson L, Sandlund M. Reaching Older People With a Digital Fall Prevention Intervention in a Swedish Municipality Context-an Observational Study. Front Public Health. 2022 Apr 25;10:857652. doi: 10.3389/fpubh.2022.857652. eCollection 2022.

Reference Type: DERIVED

PMID: 35548075 (View on PubMed)

Other Identifiers

SafeStepReach

Identifier Type: -

Identifier Source: org_study_id