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

NCT04161625 | Completed

• 1 other identifier: SafeStepReach
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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

Keywords

Prevention and control; Exercise therapy/methods*; Aged 70 and over; Smartphone; Computers handheld; Motivation; Behaviour change; Postural balance; Health behaviour; mHealth; eHealth; Digital health; Self-management; Re-aim

Outcome Measures

Primary Outcomes (1)

• Reach

  The number of participants in relation to estimated size of total target population

  12 months

Secondary Outcomes (24)

• Sociodemographic characteristics age

  Baseline

• Sociodemographic characteristics gender

  Baseline

• Sociodemographic characteristics living conditions

  Baseline

• Functional leg strength

  [Time Frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months]

• Perceived Exertion

  Change; Baseline, 3 months, 6 months, 9 months, 12 months

Study Arms (1)

Safe Step - digital exercise program

EXPERIMENTAL

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.

Behavioral: Digital exercise program with support

Interventions

Digital exercise program with support 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)

Safe Step - digital exercise program

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Caring Science Buildning, Umeå University

Umeå, 90187, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35548075 DERIVED

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marlene Sandlund, Ass Prof

  Umeå universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pragmatic clinical trial evaluating reach, effects and cost effectiveness of a mobile health application. The intervention will last for 12 months with follow-up assessments at 3, 6, 9 and 12 months.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: November 13, 2019
• Study Start: October 14, 2019
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available from the corresponding author on reasonable request.
• Access Criteria: Data will be available from the corresponding author on reasonable request. The protocol will be published in an open access journal.

Locations

SE (1)