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

NCT04437238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2022-04-13

No results posted yet for this study

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).

Conditions

Interventions

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.

OTHER

Control - Usual care

Participants allocated to the control condition will receive care as usual.

Sponsors & Collaborators

  • Unity Health Toronto

    collaborator OTHER
  • Sunnybrook Health Sciences Centre

    collaborator OTHER
  • North York General Hospital

    lead OTHER

Principal Investigators

  • Monika Kastner, PhD · North York General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-03-31
Completion
2022-04-12

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04437238 on ClinicalTrials.gov