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Trial record 7 of 248 for:    pragmatic | Canada

Pilot Evaluation of "KeepWell" Using a Hybrid Effectiveness-Implementation Pragmatic Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437238
Recruitment Status : Completed
First Posted : June 18, 2020
Last Update Posted : April 13, 2022
Sponsor:
Collaborators:
Unity Health Toronto
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Monika Kastner, North York General Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Chronic Disease Other: KeepWell tool Other: Control - Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Consenting participants will be randomly allocated to the intervention (KeepWell) or control (usual care) using a random number generator; allocation will be concealed. 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.
Primary Purpose: Health Services Research
Official Title: Effectiveness of an eHealth Tool for Older Adults With Multimorbidity ("KeepWell"): Protocol for a Hybrid Effectiveness-implementation, Pragmatic Randomized Controlled Trial
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : April 12, 2022


Arm Intervention/treatment
Experimental: Intervention - KeepWell tool
KeepWell is standalone eHealth application aimed at supporting the self-management of older adults with multimorbidity, and it has the following features: (i) 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 health (chronic diseases), lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social and emotional well-being (social frailty, isolation, loneliness) dimensions; (iv) an evidence-based, customized Action plan; (v) an interactive lifestyle tracker; (vi) journaling; (vii) and a health resources library. 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.
Other: KeepWell tool
KeepWell is standalone eHealth application aimed at supporting the self-management of older adults with multimorbidity, and it has the following features: (i) 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 health (chronic diseases), lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social and emotional well-being (social frailty, isolation, loneliness) dimensions; (iv) an evidence-based, customized Action plan; (v) an interactive lifestyle tracker; (vi) journaling; (vii) and a health resources library. 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.

Placebo Comparator: Control
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.
Other: Control - Usual care
Participants allocated to the control condition will receive care as usual.




Primary Outcome Measures :
  1. Self-efficacy [ Time Frame: Measured at baseline and 6 months of follow-up ]
    Self-efficacy for managing chronic disease (6-item scale)


Secondary Outcome Measures :
  1. Implementation [ Time Frame: Measured at 3 and 6 months of follow-up ]
    Measurement of change between 3 and 6 months follow-up in implementation outcomes (reach, adoption, fidelity, maintenance, acceptability, appropriateness, feasibility)

  2. Patient reported outcomes [ Time Frame: Measured at 3 and 6 months of follow-up ]
    Change between 3 and 6 months of follow-up in self-reported disease management, perceived health and functional status, emotional well-being, quality of life

  3. Change between 3 and 6 months of follow-up in patient reported experiences [ Time Frame: Measured at 3 and 6-months of followup ]
    Self-reported patient activation, empowerment, patient-practitioner communication, shared decision-making.


Other Outcome Measures:
  1. Self-efficacy [ Time Frame: Measured at 3 months of follow-up ]
    Self-efficacy for managing chronic disease (6-item scale)

  2. The total cost of implementing KeepWell [ Time Frame: Cumulative, reported at 6 months of follow-up ]
    Cost description analysis to assess the total cost of implementing KeepWell



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

(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, 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.

Exclusion criteria:

(i) Non-English speaking; (ii) no access to a computer or tablet device; (ii) no email address; and (iii) unable to consent (as assessed by the MacCAT-CR tool)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437238


Locations
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Canada, Ontario
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Sponsors and Collaborators
North York General Hospital
Unity Health Toronto
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Monika Kastner, PhD North York General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Monika Kastner, Research Chair, North York General Hospital
ClinicalTrials.gov Identifier: NCT04437238    
Other Study ID Numbers: KeepWell RCT
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share de-identified participant level data with our bio-statistician. We will share this information through encrypted, secured hospital email. We will also share all IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: We will share supporting information at the beginning of the study for the purposes of sharing the plan with the research team and providing them with the opportunity to provide feedback on supporting information (2-4 weeks), and IPD at the conclusion of our study for the purposes of data interpretation and analysis (2-4 weeks).
Access Criteria:

The biostatistician and health economist will have access to PID to perform the analysis of primary and secondary outcomes including the cost analysis. They will have access to the data via an encrypted file via secured hospital email for 2-4 weeks or longer if needed (no more than 8 weeks).

The biostatistician 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 and perform subgroup analyses. For the cost description analysis, the health economist will estimate the cost to delivering KeepWell, 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. All outcomes will be assessed according to intention to treat.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Monika Kastner, North York General Hospital:
Older adults
Multimorbidity
Web-based intervention
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes