Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05789225 |
| Other study ID # |
2022-02553 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 8, 2024 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Karolinska Institutet |
| Contact |
Charlotte Ytterberg, PhD |
| Phone |
+46702721984 |
| Email |
charlotte.ytterberg[@]ki.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this randomized controlled trial is to evaluate the effects of a digital group
based self-management fall prevention program, "Fewer Falls in MS", in people with multiple
sclerosis (PwMS). The main questions it aims to answer are:.
- Is the Fewer falls in MS program effective in reducing fall incidence in PwMS at 6 and
12 months after start of intervention?
- Does the program have an effect on secondary outcomes at 3, 6 and 12 months?
- How do process evaluation components (context, implementation, mechanisms of impact)
inform interpretation of outcomes?
- What is the cost effectiveness of the fall prevention program 12 months after start of
intervention?
Participants in the intervention group will participate in a group-based self-management fall
prevention intervention of eight 2-hour sessions delivered online by a group leader. The
group leader will participate in an online education program before intervention start. Home
assignments are completed by the participants between group sessions. Participants in the
intervention group and the control group will receive a brochure on fall risk factors and
fall prevention
Researchers will compare the intervention group and the control group to see if there are any
differences in fall incidence, sense of control of falls prevention, fear of falling, falls
self-efficacy, activity curtailment, perceived impact of MS, self-reported health, and health
economic costs. Researchers will also study factors and mechanisms that support or hinder how
the fall prevention program builds participants' ability to manage their fall risk; and if
and how PwMS have implemented and use self-management fall prevention behaviours into their
daily lives.
Description:
Purpose and aims The overall purpose is to evaluate an online fall prevention programme for
ambulatory and non-ambulatory people with multiple sclerosis (PwMS). The programme
incorporates key features of self-management and addresses a variety of fall risk factors.
The effects of the programme in decreasing number of falls will be evaluated in a full scale
randomised controlled trial (RCT). The hypothesis is that after participating in the
programme, PwMS will identify and self-manage risk factors for falls in their everyday life
while taking the daily fluctuations of multiple sclerosis (MS) into consideration (i.e.,
develop fall prevention behaviours), and thereby reduce the number of falls.
Aims:
1. To determine if the fall prevention programme is effective in reducing falls in PwMS 6
and 12 months after start of intervention.
2. To determine if the program has an effect on secondary outcomes at 3, 6 and 12 months.
3. To explore how process evaluation components (context, implementation, mechanisms of
impact) inform interpretation of outcomes.
4. To evaluate the cost effectiveness of the fall prevention program at 12 months after
start of intervention.
INTRODUCTION MS is a chronic inflammatory, demyelinating, and neurodegenerative disease with
a global prevalence of about 36 per 100,000 population. The prevalence in women is two to
four times higher than in men and the usual onset is between 20 and 40 years of age. The
disease is typically progressive in nature with consequences that include an increased risk
for falls. Up to 71% of PwMS fall each six months (1). Those who report a fall in the past
year have an 82% probability of falling again in the six months after a fall and a 56%
probability of sustaining an injurious fall (1). Falls among PwMS are associated with
injuries, fear of falling and low health-related quality of life (2).
Several consequences of MS are known fall risk factors for this population, including
impaired balance, reduced walking speed, and impaired cognition (2). The lack of attention
given to behavioural and environmental influences on fall risk for PwMS is a major gap in
existing evidence. Another major gap in MS falls research is that few studies have explored
influences on fall risk among individuals who are non-ambulatory, i.e., only capable of
walking a few steps or not at all (3). Furthermore, most interventions aiming to prevent
falls among PwMS have excluded non-ambulatory individuals. To date, only two research teams
are addressing the fall prevention needs of non-ambulatory PwMS: ours and a team based in the
U.S. (4). The importance of targeting a variety of modifiable risk factors through fall
prevention programs for PwMS has been highlighted (5). The need for comprehensive approaches
to fall prevention that address physical, environmental, and behavioural aspects of falls
management has been echoed by Gunn et al (6). Despite the recognition of the value of
attention to diverse influences on fall risk, most fall prevention interventions for PwMS
focus only on addressing physical impairments, such as compromised balance.
For PwMS, who live with an unpredictable disease and daily fluctuations in functioning, the
benefits of self-management (7) of the multifactorial fall risks have been highlighted (8).
Nevertheless, research on self-management interventions to prevent falls in PwMS is in its
infancy. The delivery and settings of previous interventions have been face-to-face in
physical locations, supported by online resources, or web-based without any in real-time
interactions. Our proposed self-management intervention will be enhanced by digital health
technologies with real-time digital meetings and online learning platforms. For PwMS, such
delivery will require less time and no expenses for travelling, reduced impact on fatigue,
and have the possibility to reach people also in sparsely populated areas.
The intervention To address the unique fall prevention needs of ambulatory and non-ambulatory
PwMS, we have designed an online self-management fall prevention intervention. The
intervention is a complex intervention, given its number of interacting components; the
number and difficulty of behaviours required by both those delivering and receiving the
interventions; and the number of outcomes addressed. The intervention was developed informed
by findings from our scoping review (manuscript submitted), social cognitive theory (SCT)
(9), and using a co-design method (10), based on design thinking (11), with the goal of
enhancing the intervention's quality and relevance to end users. The co-design process
(including pre-planning, the workshops, and the refinement phase) captured feedback from
various stakeholders (PwMS, the patient organisation Neuro Sweden and healthcare
professionals); and resulted in a manualized, online fall prevention programme.
The programme is group-based with maximum 8 participants; led by a trained facilitator; and
performed in eight two-hour sessions, the first seven over seven consecutive weeks and the
last final session held one month after the seventh session. The sessions are face-to-face
digital meetings by use of a video platform (Zoom Video Communications, Inc.). An online
learning platform (BASS) is used to share intervention content including assignments to be
completed by participants between sessions, and for asynchronous activities and communication
with the facilitator that can be shared between participants outside the sessions. The
assignments are designed to provide participants with opportunities to practice skills
learned during the fall prevention programme. One facilitator will lead each programme cycle,
i.e., the eight sessions. The intervention focuses on six core self-management skills (7):
problem solving, decision-making, using resources, partnership with healthcare providers,
taking action, and self-tailoring. The components of the intervention are theoretically
grounded in SCT (9) including observational learning, persuasion and support, and
opportunities for skill mastery. The pedagogical format is theoretically grounded in
universal design for learning (12) and principles for collaborative learning with blended
methods (digital tools and learning platform involved) (13). Universal design for learning
emphasizes the importance of designing an intervention to enable participants of various
abilities to assimilate the knowledge using different forms of engagement, materials, action,
and expression. The blended learning design adds to this by structuring the sessions
according to principles for group collaboration in an online setting. Each of those features
are reflected in the intervention.
To support program fidelity the group leaders will complete a train-the-trainer program prior
to the intervention start. This online education program consists of asynchronous online
modules providing information on: the fall prevention programme aim, structure, and content;
theoretical grounding of the fall prevention programme; the role of the group leader; basic
knowledge on MS, and on falls in MS; how to use an action plan; and detailed content of the
eight session manuals. Each train-the-trainer module ends with a quiz or a reflective
question. One module of the train-the-trainer program consists of a synchronous online
role-play session. In addition, the group leaders will receive a manual that describes how
the program's digital tools are used.
The intervention is currently evaluated in a feasibility study (14) comprising 46
participants: 23 have been randomized to participate in the group-based self-management
intervention and 23 have been randomized to the control group. Analyses of feasibility of
delivery of the intervention, intervention fidelity, feasibility of outcome measures, and
acceptability of the intervention from the perspectives of both the PwMS who participated in
the intervention and facilitators are ongoing. Preliminary findings show that the recruitment
process, the data collection procedures, and the intervention procedures are feasible.
Methods Consistent with the Medical Research Council's recommendations for development and
evaluation of complex interventions, the fall prevention programme will be evaluated
regarding outcome and process with quantitative and qualitative methods. To ensure patient
benefit, MS-specific representatives from the patient organisation Neuro Sweden have been
project partners in the programme development and feasibility testing. They will continue to
be project partners in this effectiveness study through ongoing collaborative discussions on
project procedures, for example development of interview questions.
Effect study Aims: To determine if the fall prevention programme is effective in reducing
falls in PwMS 6 months and 12 months after start of intervention; and To determine if the
program has an effect on secondary outcomes at 3, 6 and 12 months.
Participants: Eligible participants will be community dwelling PwMS aged ≥ 18 years, who are
able to independently transfer from bed to wheelchair with or without aids but without
assistance of another person, have experienced one or more falls during the last year, are
able to understand and communicate in Swedish; and have ability to use and access to cell
phone and technical devices for online meetings i.e., computers or tablets with internet
access. Participants will be recruited from in- and outpatient MS- and rehabilitation
clinics, by the patient organization Neuro Sweden and by social media advertisements.
Power calculation: The literature suggests that 71% of PwMS fall each 6 months (1). Based on
the estimation that the intervention will reduce the falls incidence to 50% in the
intervention group, and allowing for approximately 15% dropout, the recruitment target is set
to 104 participants in each group (80% power, p=0.05, 2-sided).
Design and procedures: A parallel-group RCT will be conducted. After informed consent,
digitally collected through BASS electronic data capture tools hosted at Karolinska
Institutet, participants will be allocated to intervention or control group. Participants
(n=208) will be stratified for ambulation level (ambulatory/non-ambulatory) and a 1:1
allocation ratio of blocks of eight will be used. Intervention-group participants will
participate in the fall prevention programme. Control-group participants will receive a
brochure about fall risk factors and fall prevention in addition to the standard MS care and
rehabilitation. Baseline data and follow-up assessments will be collected and managed using
BASS, except short version of Montreal Cognitive Assessment which will be collected through
telephone (see below). .
Approximately eight facilitators will be recruited to lead one or more cycles of the fall
prevention programme in parallel groups. This will ensure that the outcomes of the programme
are not attributed to an individual facilitator. The facilitators will not be involved in the
usual care of the participants.
In both groups, falls will be monitored from baseline via an online short message service
(SMS). An SMS will be sent once a week (to avoid recall bias) asking "Have you fallen within
the last week?" Participants answering "yes" will receive a questionnaire through BASS with
questions on fall related injuries. Fall is defined as "an unexpected event in which the
participants come to rest on the ground, floor, or lower level". In line with recommendations
for evaluation of fall prevention interventions the monitoring of falls will continue until
12 months after start of intervention.
Data-collection: Baseline data include sociodemographic (e.g., age, sex, civil status, work
status) and disease-related characteristics (e.g., MS severity); expectations on the
programme; self-reported falls in the previous 6 months, health literacy (HLS-EU Q16),
depression/anxiety (Hospital Anxiety and Depression Scale), fatigue (Fatigue Severity Scale),
cognition (short version of Montreal Cognitive Assessment), and the outcomes. Primary outcome
is fall incidence. Secondary outcomes include data on self-management fall prevention
behaviours assessed by the Falls Control Scale; a direct measure of fear of falling; falls
self-efficacy assessed by the Revised Short Falls Efficacy Scale International, Short Falls
Efficacy Scale-International (ambulatory participants) and the Spinal Cord Injury Fall
Concern Scale (non-ambulatory participants); ; a direct measure of activity curtailment;
perceived impact of MS assessed by the Multiple Sclerosis Impact Scale; and health status by
the EuroQol-5D-5L. Data will be collected at baseline, directly after the last session, and 6
and 12 months after start of intervention.
Analyses: Intention-to-treat and per protocol analyses will be performed. Per protocol
analyses will include participants who fulfil content adherence, i.e., completion of at least
two action plans. Descriptive statistics will be used to present data. Linear mixed models
analyses will be used for the primary outcome and normally distributed secondary outcomes.
Non-parametric methods will be used for between- and within-group analyses for categorical
and non-normally distributed secondary outcomes. Primary endpoint is 6 months after start of
intervention. In addition, analyses of sustainability will be performed after 12 months.
Analyses will be performed and reported in accordance with the Consolidated Standards of
Reporting Trials guidelines for RCT. A data management plan is established and stored at the
Research Data Office at Karolinska Institutet.
Process evaluation Aim: To explore how process evaluation components (context,
implementation, mechanisms of impact) inform interpretation of outcomes.
Design: A mixed methods process evaluation. Participants: a) A purposively selected sample of
intervention-group participants (n=20-30) to represent variation in e.g., age, sex,
ambulation level, MS severity, and expectations on the programme. b) All facilitators.
Data collection: a) Semi-structured individual interviews with participants will be conducted
2- weeks, and 6- and 12-months after the end of intervention. The interviews will cover
experiences of participating in the study, contextual factors and mechanisms of impact. Data
from the program platform will be collected on intervention participant online activities,
e.g., the action plans. b) Background information (e.g. sex, age, profession, work-related
knowledge and experience). Structured questions collected after train-the-trainer and after
each session covering perceived preparedness and confidence in facilitating the group,
fidelity to program manual, interactions with group members, technical issues.
Semi-structured interviews conducted after train-the-trainer and after the last session
covering the facilitators perspective on experiences of participation, contextual factors,
implementation, and mechanisms of impact.
The interviews will be conducted face-to-face or through Zoom. Analysis: Qualitative content
analysis (15)- and descriptive statitics.
Health economic evaluation Aim: To evaluate the cost effectiveness of the fall prevention
program at 12 months.
Participants: All intervention and control participants. Data collection: Participants
answering "yes" on the weekly SMS about falls will receive a short questionnaire through BASS
with questions related to fall related injuries i.e., healthcare utilization, municipal care
utilization, sickness absence, medications, support from significant others, and technical
aids including walking aids. Estimations of resources needed for the fall prevention program
will be collected related to group facilitators i.e., time for participating in preparatory
training, for conducting the program, and time for preparation in between group sessions. To
estimate the monetary value of resource use, both for participants in the RCT as well as for
resources needed to conduct the intervention, cost data will be retrieved from the cost per
patient (KPP) database held at the Swedish Association of local authorities and regions
(SKR), regional pricelists as well as from Statistics Sweden (SCB). Data on health-related
quality of life will be measured using the EQ-5D-5L at all time-points.
Analyses: The PwMS participating in the new fall prevention program will be compared to the
control group using intention-to-treat analysis. Descriptive and comparative statistics will
be used for analyses of between and within group differences in health-related quality of
life and resource use of participants as well resources needed for conducting the
intervention.
Significance In contrast to previous studies of fall prevention interventions, the present is
based both on pedagogical theories and on theories on behavior change; is directed to both
ambulatory and non-ambulatory PwMS; and includes an interactive online design that
facilitates participation from people with fatigue and those in rural areas. Thereto, most
previous programmes are focused on physical activity, whereas this programme takes the
multifactorial risk factors of MS falls into consideration. Through this, participants will
learn strategies that they can apply in their everyday life in different fall risk areas and
alter strategies as the MS progresses.
If the programme is effective in reducing the number of falls, it will be of great clinical
relevance to health care providers working with PwMS. This, as well as the use of co-design
in the development and use of a manualized intervention to support programme fidelity will
facilitate implementation into existing health care for PwMS. We have MS-specific
representatives from the patient organisation Neuro Sweden as partners which ensures the
patient benefit and facilitates the dissemination of the new knowledge nationally. If
effective, we will make the programme publicly available so that it can be implemented in the
Swedish MS care. The generated new knowledge can also be used in Swedish national clinical
guidelines for treatment of PwMS.
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