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

NCT04437238 | Completed

• 1 other identifier: KeepWell RCT
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Disease

Keywords

Older adults; Multimorbidity; Web-based intervention

Outcome Measures

Primary Outcomes (1)

• Self-efficacy

  Self-efficacy for managing chronic disease (6-item scale)

  Measured at baseline and 6 months of follow-up

Secondary Outcomes (3)

• Implementation

  Measured at 3 and 6 months of follow-up

• Patient reported outcomes

  Measured at 3 and 6 months of follow-up

• Change between 3 and 6 months of follow-up in patient reported experiences

  Measured at 3 and 6-months of followup

Other Outcomes (2)

• Self-efficacy

  Measured at 3 months of follow-up

• The total cost of implementing KeepWell

  Cumulative, reported at 6 months of follow-up

Study Arms (2)

Intervention - KeepWell tool

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

KeepWell tool OTHER

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.

Intervention - KeepWell tool

Control - Usual care OTHER

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

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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)

Sponsors & Collaborators

• North York General Hospital: lead
• Unity Health Toronto: collaborator
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Related Publications (1)

• Kastner M, Makarski J, Hayden L, Hamid JS, Holroyd-Leduc J, Twohig M, Macfarlane C, Hynes MT, Prasaud L, Sklar B, Honsberger J, Wang M, Kramer G, Hobden G, Armson H, Ivers N, Leung FH, Liu B, Marr S, Greiver M, Desroches S, Sibley K, Saunders H, Isaranuwatchai W, McArthur E, Harvey S, Manawadu K, Petricca K, Straus SE. Effectiveness of an eHealth self-management tool for older adults with multimorbidity (KeepWell): protocol for a hybrid effectiveness-implementation randomised controlled trial. BMJ Open. 2021 Feb 17;11(2):e048350. doi: 10.1136/bmjopen-2020-048350.

  PMID: 33597147 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Monika Kastner, PhD

  North York General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Chair

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: June 18, 2020
• Study Start: November 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 12, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

CA (1)