Clinical trial NCT04161625: Evaluation of Reach, Effects and Cost Effectiveness of a Fall Preventive Intervention Including a mHealth Application
Official title: Evaluation of Reach, Effects and Cost Effectiveness of a Fall Preventive Intervention Including a mHealth Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 173
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Reach
timeFrame: 12 months
Secondary outcomes:
measure: Sociodemographic characteristics age
timeFrame: Baseline
measure: Sociodemographic characteristics gender
timeFrame: Baseline
measure: Sociodemographic characteristics living conditions
timeFrame: Baseline
measure: Functional leg strength
timeFrame: [Time Frame: Change; Baseline, 3 months, 6 months, 9 months, 12 months]
measure: Perceived Exertion
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Self-rated balance
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Self-rated leg-strength
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Falls efficacy
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Health related quality of life
timeFrame: Change; Baseline, 3 months, 6 months, 9 months, 12 months
measure: Use of the information videos
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Experienced positive effects of the exercise intervention
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Experienced negative effects of the exercise intervention
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Physical activity
timeFrame: Change: Baseline, 12 months
measure: Exercise adherence throughout the intervention
timeFrame: 12 months
measure: Self-rated improvements in balance
timeFrame: 12 months
measure: Self-rated improvements in leg-strength
timeFrame: 12 months
measure: Rate of attrition
timeFrame: 12 months
measure: New exercise routines
timeFrame: 12 months
measure: Costs related to the interventions
timeFrame: 12 months
measure: Cost-effectiveness
timeFrame: 12 months
measure: Participation in technical support sessions
timeFrame: 12 months
measure: Participation in try-out group exercises
timeFrame: 12 months
measure: Fall rate
timeFrame: 12 months
measure: Number of fallers
timeFrame: 12 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Caring Science Buildning, Umeå University
Study officials:
affiliation: Umeå universitet
name: Marlene Sandlund, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.