Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04437238 |
| Other study ID # |
KeepWell RCT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2020 |
| Est. completion date |
April 12, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
North York General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The burden of chronic disease is a global phenomenon, particularly amongst seniors. Aging is
an expensive process. In Canada, 10% of seniors who have the most complex health needs
account for 60% of the total annual health care spending in many provinces. Given these
projections, we need to adapt our current models of care. In response, different chronic
disease management tools have been created with a central aim to facilitate ongoing,
proactive and preventive support for optimal chronic disease management. In particular,
self-management tools have been acknowledged as an effective way to optimize disease
management and are easily scalable and can reach a broader population of older people with
chronic diseases. In fact, online self-management tools are particularly relevant for
supporting seniors with complex care needs in their homes; and they are interested in using
the Internet and social media. However, interventions and tools seldom consider all aspects
of disease management, are not usually developed specifically for seniors or created for
sustained use and are primarily focused on a single disease. As such, the projected health
outcomes of seniors continue to remain poor, and the quality and efficiency of care remain
sub-optimal. To respond to these challenges, we created an eHealth self-management
application called "KeepWell" that supports seniors with complex care needs in their homes.
It is a patient-centered, multi-chronic disease management tool that incorporates the care
for two or more chronic conditions from among the top high-burden chronic diseases. KeepWell
was built on a strong evidentiary base including several knowledge syntheses, a co-design
process with our integrated knowledge translation team involving patients, researchers,
clinicians and developers; and a usability and pilot evaluation. The objectives of our study
will be to evaluate the effectiveness, economic impact and uptake of KeepWell in a 6-month,
pragmatic, hybrid effectiveness-implementation randomized controlled trial (RCT).
Description:
Methods
Design We will evaluate the effectiveness and uptake of the KeepWell solution in a 6-month,
pragmatic, hybrid effectiveness-implementation RCT for optimizing and sustaining the
self-management of older adults with multimorbidity. We will use the type 2 design, which
facilitates the simultaneously investigation of the effectiveness of an intervention while
rigorously testing the implementation strategy. The implementation evaluation will be guided
by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.
Theoretical basis of our work We used the Knowledge-to-Action (KTA) model to guide our
methods. Our team has experience applying the KTA framework in creating technology-based
interventions [refs]. We have also adapted an integrated KT (IKT) strategy whereby all our
stakeholder team members who helped us to create KeepWell and prepare this protocol are going
to continue to steer the execution of our study. This team helped to develop the objectives,
project plan and timelines; discussed potential barriers and mitigating strategies, and
monitored progress.
Population and recruitment Older adults will be identified with support from: (i) the
University of Toronto Primary Care Research Network (UTOPIAN); (ii) the Retired Teachers of
Ontario (RTO); and (iii) our clinician (geriatricians and family physicians) partnering
sites: North York General Hospital, St. Michael's hospital of Unity Health, Sunnybrook
healthcentre, and St. Peter's hospital. All these recruitment sources have a roster of older
adults with multiple chronic conditions via their affiliated primary care and geriatric
clinics. We have created a recruitment poster that will be administered at each site
according to a procedure most feasible and practical for their practice flow and resources.
For example, the poster may be administered directly to older adults by family physicians and
geriatricians during a visit or through their clinic staff upon registering for a visit or
posted on walls. In addition, the poster will be distributed via an email listserv from our
patient partner organization, the RTO with a membership of more than 70,000 older adults.
Study eligibility criteria are: (i) age 65 years; (ii) have one or more of the following
chronic conditions: diabetes, heart failure, cardiovascular disease, dementia, chronic kidney
disease, osteoporosis, osteoarthritis, rheumatoid arthritis, Chronic Obstructive Pulmonary
Disease (COPD), depression, urinary incontinence, stroke; (iii) English speaking; (iv) access
to a computer or tablet device; (v) have an email address; and (vi) able to consent.
Consent-giving capacity will be assessed using the validated "MacCAT-CR" tool.
The recruitment poster includes a phone number and email address dedicated to this research
project. Potential participants will self-refer after reviewing the poster, by contacting the
research coordinator using one of two strategies: (1) if their mode of reply is by phone, the
research coordinator will review the study information sheet and consent process document
with potential participants and answer any questions. Study eligibility will also be
assessed. Participants will have the option to consent over the phone or via an online survey
(SurveyMonkey). Non-consenting respondents will be asked to provide a reason for their
decision; (2) if the mode of reply is email, an automated, email response system will be
initiated. The email will include the same study and consent process information as described
for the phone option and a link to a survey (via SurveyMonkey) that will include questions to
assess their eligibility and to obtain conent. Regardless of participants' mode of reply,
they will be enrolled and assigned a unique identification number and randomization sequence
as soon as the research coordinator receives confirmation of eligibility and consent. Once
they do, participants will receive an email with a link to KeepWell and their unique login
details (intervention condition) or to a link to an online survey to complete a risk
assessment questionnaire (usual care control condition).
Randomization and blinding Consenting participants will be randomly allocated to the
intervention (KeepWell) or control (usual care) using a random number generator. Consenting
participants will be assigned a login and password by the research coordinator, which they
can use to access the KepWell tool. Each individual login and password will be randomly
allocated into intervention or control using a 1:1 ratio; participants will be the unit of
randomization. The research coordinator will have the master list of logins and allocation.
Allocation will thus be concealed because this list will not be shared with the research
team. To protect against sources of bias, investigators, outcome assessors and data analysts
will be blinded to the randomization sequence. Blinding of older adults will not be possible
given that the intervention is a standalone, web-based tool and the control condition is
usual care.
Intervention and Control KeepWell is a fully functional, standalone eHealth application aimed
at supporting the self-management of older adults with multimorbidity. KeepWell can be used
on any electronic device and has innovative features that most other chronic disease
solutions don't have: (i) a multi-disease focus (it can generate lifestyle advice for any
combination of the top 10 chronic conditions affecting older adults); (ii) an avatar health
coach that walks users through a health prioritization and goal setting exercise; (iii) a
health risk questionnaire (HRQ) covering three risk dimensions: health (chronic diseases),
lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social
and emotional well-being (social frailty, isolation, loneliness); (iv) an evidence-based
Action plan with lifestyle advice customized to user's risks; and (v) other eHealth
self-management tactics that have been shown to improve outcomes (interactive lifestyle
tracker, journaling. A health coach avatar leads users through a health priority and goal
setting exercise that allows them to create a customized action plan based on guideline
recommendations for lifestyle changes. Users can then put their plan into action through a
lifestyle tracking feature that allows them to track their progress in their identified
lifestyle areas. KeepWell also has an extensive resource library, which has links to
additional high-quality health and lifestyle information across topics of interest to older
adults. Participants allocated to the control condition will receive care as usual but will
be asked to complete the health risk questionnaire at baseline, 3- and 6-month follow-up via
an online survey to collect outcomes data. The control group will receive full access to
KeepWell at the conclusion of the study.
Outcomes Primary outcome: perceived self-efficacy for managing identified chronic diseases or
risks measured at 6-months follow-up using a validated 6-item, self-efficacy scale, which is
embedded within the health risk questionnaire of the KeepWell platform. We selected this
outcome because increasing self-efficacy is a prerequisite for behaviour change which,
through improved self-management may influence health and healthcare use. All participants
will complete this outcome assessment via the health risk questionnaire of KeepWell at
baseline, 3- and 6-month follow-up.
Secondary outcomes: (i) self-efficacy at 3-months follow-up; (ii) cost description analysis
to assess the total cost of implementing the KeepWell overall and by stage (e.g., one-time
costs vs. ongoing costs); (iii) implementation outcomes according to Proctor et al: reach
(access), adoption (uptake, utilization); fidelity; maintenance; acceptability
(satisfaction), appropriateness (relevance), feasibility; (iv) patient reported outcomes
(self-reported disease management, perceived health and functional status, emotional
well-being, QOL); (v) patient-reported experiences (self-reported patient activation,
empowerment, patient-practitioner communication, shared decision-making). Outcomes will be
measured using the health risk questionnaire embedded within KeepWell and an online survey at
final follow-up.
Sample size calculation An increase in self efficacy of 40% is considered significant and has
been achieved in other studies of self-management interventions including one of the highest
quality studies of a chronic disease self-management program. In their Cochrane review of
lay-led self-management interventions, Foster et al found 10 studies that looked at self
efficacy and these interventions showed a small, statistically-significant improvement
(standardized mean difference -0.30, 95% confidence interval (CI) -0.41 to -0.19). Using
these estimates to calculate our sample size, targeting a power of 0.8 and assuming a dropout
rate of 25%, we estimate that 220 older adults are needed per group for a total of 440
participants. In a previous interrupted time series study, an Osteoporosis self-management
tool housed in a touch-screen laptop computer was implemented across 3 primary care practices
for 12 months, with a total of 350 patients who completed the risk assessment questionnaire,
so our proposed sample size of 440 patients is feasible, given our hospital and primary care
partnerships.
Analysis We will perform descriptive statistics (binary outcomes) and means and standard
deviations (continuous outcomes). For the primary outcome, a general linear model will be fit
to investigate differences between groups in self-efficacy at 6 months. We will adjust for
potential confounders (including baseline self-efficacy) and perform subgroup analyses
(patient chronic conditions, risk factors, mode of KeepWell use [Tablet/Laptop], age group
[65-74, 75-84, 85+], sex and gender). We will use the chi-squared and Fisher's exact test to
compare binary outcomes and independent two sample t-tests for continuous outcomes. We will
adjust for potential confounders in the final analysis (e.g., receipt of education about
chronic diseases and risks or specialist referrals); and perform subgroup analyses (e.g.,
setting, gender, and age: 65-74 and 75+). We will perform visual investigation (through
scatter plot displays) and analytical outcomes along with logistic regression analyses to
determine whether unique patient characteristics predict thresholds of use for different
KeepWell components. To examine the change in self-efficacy over time between groups
(incorporating self-efficacy scores at baseline, 3- and 6- months), we will use a linear
mixed-effects model. For the cost description analysis, we will estimate the cost to
delivering KeepWell from the public healthcare payer perspective, including out-of-pocket
costs for patients, technical costs for the clinic, efficiencies gained, estimated health
care utilization increases / reductions; and exploration resource costs required (e.g.,
online data collection / analysis, web system testing / hosting). The KeepWell platform
collects user data for these measures, so we will be able to track them longitudinally to
observe how the solution impacts on outcomes. The findings from the economic analysis will
represent the potential preliminary economic impact of KeepWell to the healthcare system. All
outcomes will be measured at baseline, 3- and 6-months follow-up and assessed according to
intention to treat. All statistical analyses will be carried out using the R statistical
software.
