Chronic DiseaseNCT02917954
Electronic Patient Reported Outcome (ePRO) Mobile Application Pragmatic Trial
A study testing ePRO Tool Intervention in people with Chronic Disease and Quality of Life, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Canadian and international health care systems require solutions on how to address the needs of a relatively small population that take up a large portion of health care resources. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Quality of Life
- What is being tested?
- ePRO Tool Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2017to 19 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a FHT patient at one of the FHT sites selected and is 60 years or older;
- physical capability to use a tablet and/or a caregiver who can use the tablet on their behalf;
- ability to read and write in English and/or the availability of a caregiver who can do so on their behalf;
- has complex care needs defined as two or more chronic conditions and 10 or more visits to their primary health care provider within the last 12 months; and
- be thinking about or ready to make changes to support their self-management.
- In addition patients can self-identify and join the study, as well as providers can identify other patients they feel fit our eligibility criteria that may not have been pulled from the EMR system. This allows eligible patients to enroll into the study that may have been missed when identifying patients through the EMR system.
Who cannot join
- 1. Absence of Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Full Evaluation, Scale and Spread: Pragmatic Trial of the HSPRN-Bridgepoint Electronic Patient Reported Outcome (ePRO) Mobile Application to Support the Needs of Persons With Complex Chronic Disease and Disability
Canadian and international health care systems require solutions on how to address the needs of a relatively small population that take up a large portion of health care resources. In Ontario, 10% of the population accounts for 79% of total system costs, with similar trends found in other parts of Canada and internationally. Most high-cost users are seniors, older adults, with multiple chronic conditions and complex care needs who are living in the community. Beyond the cost issues, older adults experiencing multi-morbidity are at higher-risk of poor health outcomes and experience lower quality of life as compared to individuals experiencing single illness only.
Since April 2013 the electronic Patient Reported Outcomes (ePRO) mobile application and portal, has undergone a multi-phased, user-centred design evaluation approach to develop a tool designed to meet the needs of older adults with complex care needs and their primary care providers. The ePRO tool is designed to collect person-centred, person-reported indicators to improve care by supporting primary care delivery and enhancing patient self-management.
The ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal Tracker allows patients and providers to collaboratively create goal-oriented patient care-plans, and helps patients to track outcomes related to their goals using a mobile device. The Health Journal allows patients, their caregivers and primary care providers to monitor patients' symptoms and outcomes. The ePRO tool was re-evaluated and modified following each previous study phase (I-IV). This project marks the final phase of the study in which the investigators will conduct a pragmatic trial of the ePRO tool in 8-16 Family Health Teams in Ontario through a stepped-wedge randomized trial with an embedded case study. In this evaluation of the tool the investigators will assess outcome, process and context measures to identify how the tool affects patients, providers and the system at point-of-care.
Read the detailed description
The pragmatic trial will take place at 6 Family Health Teams (FHTs) to a maximum of 16 FHTs in Ontario utilizing a stepped-wedge randomized method with an embedded case study of implementation at four sites. The research team will observe provider-patient goal-setting visits at the time of onboarding onto the intervention. Additional consent will be obtained from the patient and provider prior to initiating the observational visit. In addition, the research team will attend FHT rounds at the identified case study sites (when appropriate) to observe and document how providers discuss and set goals in an interdisciplinary team environment. Using a stepped-wedge design, each FHT will receive the ePRO tool (intervention) but will be randomized on when in the stepped-wedge design they will receive the intervention. The stepped-wedge randomization will assign (through number generator or coin flip) each of the FHTs to either a: 1) 3 month control period and a 12 month intervention period, or 2) 6 month control period and a 9 month intervention period; and their respective participants will be assigned accordingly.
Providers and patients recruited at all sites will receive training on how to use the ePRO tool prior to the start of the trial. During the intervention period, patients will receive one-on-one training with a research assistant; and provider training will occur in a group setting. Training will be led by a member of the research team and will take between 30-60 minutes. Patients and providers will also be provided with a manual and training video on how to use the tool and portal, and the patients will be offered refresher sessions (individual or group) every 3 months over the duration of the study.
Following consent, all patients will complete pre and post surveys every 3 months (through control and intervention periods). Patients will also complete an additional survey at study closeout to capture tool usability feedback. We anticipate survey completion to take 20-35 minutes.
Additionally, patients are requested to attend a minimum of two schedule appointments with their provider during the study. The first (on-boarding) visit will have the patient and provider collaboratively discuss and set monitoring protocols for tracking. The second (off-boarding) visit, following the monitoring period, will allow patients and providers to privately discuss their experience with the ePRO tool, before participating in their respective focus group or interview. As was the case in our usability pilot and exploratory trial, we anticipate that patients will have additional appointments with their providers during the study at which point they can use the tool to discuss patient progress towards goals. All patients are requested to attend 4-5 scheduled appointments with their provider during the study. In accordance to earlier study phases on-boarding and off-boarding visits typically take 30 minutes. Other scheduled visits take between 10-30 minutes depending on the type of visit and provider they are seeing.
Embedded within the pragmatic trial will be case studies of 4 intervention sites. Provider and patient participants at case sites will participate in mid and post-intervention period semi-structured interviews to capture implementation enables and barriers. To adequately capture organizational level barriers and enablers we will additionally conduct semi-structured interviews with organizational leaders (executive directors and/or clinical leads). We will also collect relevant documents from all sites (i.e. organizational policies regarding the use of mobile applications or provider trainings and manuals in using technology as part of usual care).
This described stepped-wedge design is an update from the initially conceived pragmatic cluster trial of 22 sites. This shift was necessary due to site recruitment challenges experienced, in particular that sites did not want to be recruited to the study unless they could use the technology. As such a stepped-wedge trial was deemed more appropriate. With this new design the updated power calculation for the study indicated a new target of 176 patients across sites whereas the initial calculation was for 660.
Stepped-wedge sample size calculation:
Minimum sample size required for the recruitment of sites and patients was determined using closed-form analytical formulae with a power of 80% based on: a minimal clinically important difference of our core measure of quality of life (the AQoL-4D) of 0.06, an expected standard deviation in AQoL of 0.22, an expected ICC of 0.01 (calculated based on total primary care utilization over a one year period among a 10% sample of the Ontario population, which served here as a proxy measure for patient outcomes), and an expected attrition rate of 10% (rated based on previous studies in similar population groups using similar technology). A minimum sample size of 176 patients was calculated.
- Conditions
- Chronic Disease, Quality of Life
- Being tested
- ePRO Tool Intervention
- Keywords
- eHealth/mHealth solutions, complex care needs, seniors, patient-centred care, goal-oriented care, primary health care, implementation, pragmatic trial, health outcomes, cost-effectiveness analysis
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePRO Tool InterventionDevice
Also called Electronic Patient Reported Outcome Mobile Application, ePRO
The ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal Tracker allows patients and providers to collaboratively create goal-oriented patient care-plans, and helps patients to track outcomes related to their goals using a mobile device. The Health Journal allows patients, their caregivers and primary care providers to monitor patients' symptoms and outcomes.
| Study group | Role | What they receive |
|---|---|---|
| ePRO Control (3 or 6 months) | No intervention | Control participants will complete surveys at baseline, 3 months, and/or 6 months. Surveys will capture patient demographics, their assessment of quality-of-life, chronic disease management, and primary care experience. A part from completing these surveys, no change to routine care will be seen. |
| ePRO intervention (12 or 9 months) | Experimental | During the ePRO Tool intervention participants will complete surveys at every 3 months intervals starting month at 4 or month 7, for study duration. Surveys capture patient demographics, assessment of quality-of-life, chronic disease management, primary care experience, and Electronic Patient Reported Outcome (ePRO) Mobile Application tool usability.
Participants will also meet with their provider to setup and monitor a health goal to track during the study via the ePRO application. During the study, participants will meet with their primary care providers 4-5 times to discuss their health goal monitoring. Post-study participants will discuss their experience using the ePRO app in an interview or focus group setting. Receives: Device: ePRO Tool Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Assessment of Quality-of-Life at 3 month intervals for 15 months
Our primary measure of patient oriented outcome is quality of life measured by the Assessment for Quality of Life Scale.
12 Item survey, with each item having 4 response levels.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, and study end (15-months)
Secondary outcomes (6)
ePRO cost-effectiveness - health system perspective
Only costs that are borne to the government, such as costs of intervention and costs of health services incurred during the 1-year follow-up period will be considered. Costs of the intervention will be estimated based on anticipated real-world licensing and ongoing costs for: software access, hosting and data management, program support and device management, application support, training, incremental data plan(s) (depending on volume of use in the intervention group), and for the Cloud Connect platform.
Measured: 15-months
Patient Demographic and Characteristic information
We will capture patient demographic and characteristic information such as age, gender, ethnicity, chronic illness profile, socio-economic status, and IT skills using the Patient Demographic forms.
Measured: Baseline
Provider Demographic and Characteristic Information
We will capture provider demographic and characteristic information such as age, gender, ethnicity, chronic illness profile, socio-economic status, and IT skills using the Provider Demographic forms.
Measured: Baseline
Change from baseline Patient/Caregiver Self-Reported Costs at 3 month intervals for study duration (15 months)
Patient/Caregiver Self-Reported Costs form will provide contextual information about our users to support data analysis.
Responses will be captured using a 6-point Likert scale.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, and study-end (15-months)
Change from baseline Patient Experience at 3 month intervals for study duration (15 months)
Patient Experience will be captured from the patient-experience survey distributed by the Family Health Teams of Ontario Association (AFHTO) to all Family Health Teams.
3 Item survey, with responses captured on a 5-point Likert scale
Measured: Baseline, 3 months, 6 months, 9 months,12 months, and study-end (15-months)
Change from baseline Patient Activation Measure at 3 month intervals for study duration (15 months)
Patient Self-Management will be captured by the 13-Item Patient Activation Measure. Each item will have a 5-point Likert scale response level.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, and study-end (15-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start4 May 2017
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge randomized trial. Group 1: 3 month control period followed by a 12 month intervention period. Group 2: 6 month control period followed by a 9 month intervention period.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Ottawa Hospital Research Institute, QoC Health Inc.
- Responsible party
- Principal investigator, Carolyn Steele Gray, Mount Sinai Hospital, Canada
- Investigators
- Carolyn Steele Gray, PhD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917954
- Sponsor's protocol ID
- ePRO2016
- Status last verified
- Mar 2021
- First submitted
- 13 Sep 2016
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The reported data (which includes patient information at the aggregate level) will be disseminated widely via reports, conference presentations, peer reviewed journal articles and other standard modes of knowledge translation.
Publications
Commission on the Reform of Ontario's Public Services, Public Services for Ontarians: A Path to Sustainability and Excellence. 2012.
Reid R, Evans R, Barer M, Sheps S, Kerluke K, McGrail K, Hertzman C, Pagliccia N. Conspicuous consumption: characterizing high users of physician services in one Canadian province. J Health Serv Res Policy. 2003 Oct;8(4):215-24. doi: 10.1258/135581903322403281.
PubMed 14596756Heslop L, Athan D, Gardner B, Diers D, Poh BC. An analysis of high-cost users at an Australian public health service organization. Health Serv Manage Res. 2005 Nov;18(4):232-43. doi: 10.1258/095148405774518633.
PubMed 16259671Department of Health, Long Term Conditions Compedium of Information, Third Edition, D.o. Health, Editor. 2012: United Kingdom.
Emanuel EJ. Where are the health care cost savings? JAMA. 2012 Jan 4;307(1):39-40. doi: 10.1001/jama.2011.1927. No abstract available.
PubMed 22215161Rosella LC, Fitzpatrick T, Wodchis WP, Calzavara A, Manson H, Goel V. High-cost health care users in Ontario, Canada: demographic, socio-economic, and health status characteristics. BMC Health Serv Res. 2014 Oct 31;14:532. doi: 10.1186/s12913-014-0532-2.
PubMed 25359294Marengoni A, Angleman S, Melis R, Mangialasche F, Karp A, Garmen A, Meinow B, Fratiglioni L. Aging with multimorbidity: a systematic review of the literature. Ageing Res Rev. 2011 Sep;10(4):430-9. doi: 10.1016/j.arr.2011.03.003. Epub 2011 Mar 23.
PubMed 21402176Bayliss EA, Bosworth HB, Noel PH, Wolff JL, Damush TM, Mciver L. Supporting self-management for patients with complex medical needs: recommendations of a working group. Chronic Illn. 2007 Jun;3(2):167-75. doi: 10.1177/1742395307081501.
PubMed 18083671Tahsin F, Austin T, McKinstry B, Mercer SW, Loganathan M, Thavorn K, Upshur R, Steele Gray C. Examining Use Behavior of a Goal-Supporting mHealth App in Primary Care Among Patients With Multiple Chronic Conditions: Qualitative Descriptive Study. JMIR Hum Factors. 2022 Nov 30;9(4):e37684. doi: 10.2196/37684.
PubMed 36449335Miranda RN, Bhuiya AR, Thraya Z, Hancock-Howard R, Chan BC, Steele Gray C, Wodchis WP, Thavorn K. An Electronic Patient-Reported Outcomes Tool for Older Adults With Complex Chronic Conditions: Cost-Utility Analysis. JMIR Aging. 2022 Apr 20;5(2):e35075. doi: 10.2196/35075.
PubMed 35442194Singh H, Tahsin F, Nie JX, McKinstry B, Thavorn K, Upshur R, Harvey S, Wodchis WP, Gray CS. Exploring the perspectives of primary care providers on use of the electronic Patient Reported Outcomes tool to support goal-oriented care: a qualitative study. BMC Med Inform Decis Mak. 2021 Dec 29;21(1):366. doi: 10.1186/s12911-021-01734-0.
PubMed 34965860Tahsin F, Tracy S, Chau E, Harvey S, Loganathan M, McKinstry B, Mercer SW, Nie J, Ramsay T, Thavorn K, Palen T, Sritharan J, Steele Gray C. Exploring the relationship between the usability of a goal-oriented mobile health application and non-usage attrition in patients with multimorbidity: A blended data analysis approach. Digit Health. 2021 Oct 5;7:20552076211045579. doi: 10.1177/20552076211045579. eCollection 2021 Jan-Dec.
PubMed 34868614Steele Gray C, Chau E, Tahsin F, Harvey S, Loganathan M, McKinstry B, Mercer SW, Nie JX, Palen TE, Ramsay T, Thavorn K, Upshur R, Wodchis WP. Assessing the Implementation and Effectiveness of the Electronic Patient-Reported Outcome Tool for Older Adults With Complex Care Needs: Mixed Methods Study. J Med Internet Res. 2021 Dec 2;23(12):e29071. doi: 10.2196/29071.
PubMed 34860675
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Evaluation, Scale and Spread: Pragmatic Trial of the HSPRN-Bridgepoint Electronic Patient Reported Outcome (ePRO) Mobile Application to Support the Needs of Persons With Complex Chronic Disease and Disability
- ClinicalTrials.gov ID
- NCT02917954
- Acronym / sponsor ID
- ePRO2016
- Conditions
- Chronic Disease, Quality of Life
- Keywords
- eHealth/mHealth solutions, complex care needs, seniors, patient-centred care, goal-oriented care, primary health care, implementation, pragmatic trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- University of Toronto, Ottawa Hospital Research Institute, QoC Health Inc.
- Study start
- 4 May 2017 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Canadian and international health care systems require solutions on how to address the needs of a relatively small population that take up a large portion of health care resources. In Ontario, 10% of the population accounts for 79% of total system costs, with similar trends found in other parts of Canada and internationally. Most high-cost users are seniors, older adults, with multiple chronic conditions and complex care needs who are living in the community. Beyond the cost issues, older adults experiencing multi-morbidity are at higher-risk of poor health outcomes and experience lower quality of life as compared to individuals experiencing single illness only.
Since April 2013 the electronic Patient Reported Outcomes (ePRO) mobile application and portal, has undergone a multi-phased, user-centred design evaluation approach to develop a tool designed to meet the needs of older adults with complex care needs and their primary care providers. The ePRO tool is designed to collect person-centred, person-reported indicators to improve care by supporting primary care delivery and enhancing patient self-management.
The ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal Tracker allows patients and providers to collaboratively create goal-oriented patient care-plans, and helps patients to track outcomes related to their goals using a mobile device. The Health Journal allows patients, their caregivers and primary care providers to monitor patients' symptoms and outcomes. The ePRO tool was re-evaluated and modified following each previous study phase (I-IV). This project marks the final phase of the study in which the investigators will conduct a pragmatic trial of the ePRO tool in 8-16 Family Health Teams in Ontario through a stepped-wedge randomized trial with an embedded case study. In this evaluation of the tool the investigators will assess outcome, process and context measures to identify how the tool affects patients, providers and the system at point-of-care.
Detailed description
The pragmatic trial will take place at 6 Family Health Teams (FHTs) to a maximum of 16 FHTs in Ontario utilizing a stepped-wedge randomized method with an embedded case study of implementation at four sites. The research team will observe provider-patient goal-setting visits at the time of onboarding onto the intervention. Additional consent will be obtained from the patient and provider prior to initiating the observational visit. In addition, the research team will attend FHT rounds at the identified case study sites (when appropriate) to observe and document how providers discuss and set goals in an interdisciplinary team environment. Using a stepped-wedge design, each FHT will receive the ePRO tool (intervention) but will be randomized on when in the stepped-wedge design they will receive the intervention. The stepped-wedge randomization will assign (through number generator or coin flip) each of the FHTs to either a: 1) 3 month control period and a 12 month intervention period, or 2) 6 month control period and a 9 month intervention period; and their respective participants will be assigned accordingly.
Providers and patients recruited at all sites will receive training on how to use the ePRO tool prior to the start of the trial. During the intervention period, patients will receive one-on-one training with a research assistant; and provider training will occur in a group setting. Training will be led by a member of the research team and will take between 30-60 minutes. Patients and providers will also be provided with a manual and training video on how to use the tool and portal, and the patients will be offered refresher sessions (individual or group) every 3 months over the duration of the study.
Following consent, all patients will complete pre and post surveys every 3 months (through control and intervention periods). Patients will also complete an additional survey at study closeout to capture tool usability feedback. We anticipate survey completion to take 20-35 minutes.
Additionally, patients are requested to attend a minimum of two schedule appointments with their provider during the study. The first (on-boarding) visit will have the patient and provider collaboratively discuss and set monitoring protocols for tracking. The second (off-boarding) visit, following the monitoring period, will allow patients and providers to privately discuss their experience with the ePRO tool, before participating in their respective focus group or interview. As was the case in our usability pilot and exploratory trial, we anticipate that patients will have additional appointments with their providers during the study at which point they can use the tool to discuss patient progress towards goals. All patients are requested to attend 4-5 scheduled appointments with their provider during the study. In accordance to earlier study phases on-boarding and off-boarding visits typically take 30 minutes. Other scheduled visits take between 10-30 minutes depending on the type of visit and provider they are seeing.
Embedded within the pragmatic trial will be case studies of 4 intervention sites. Provider and patient participants at case sites will participate in mid and post-intervention period semi-structured interviews to capture implementation enables and barriers. To adequately capture organizational level barriers and enablers we will additionally conduct semi-structured interviews with organizational leaders (executive directors and/or clinical leads). We will also collect relevant documents from all sites (i.e. organizational policies regarding the use of mobile applications or provider trainings and manuals in using technology as part of usual care).
This described stepped-wedge design is an update from the initially conceived pragmatic cluster trial of 22 sites. This shift was necessary due to site recruitment challenges experienced, in particular that sites did not want to be recruited to the study unless they could use the technology. As such a stepped-wedge trial was deemed more appropriate. With this new design the updated power calculation for the study indicated a new target of 176 patients across sites whereas the initial calculation was for 660.
Stepped-wedge sample size calculation:
Minimum sample size required for the recruitment of sites and patients was determined using closed-form analytical formulae with a power of 80% based on: a minimal clinically important difference of our core measure of quality of life (the AQoL-4D) of 0.06, an expected standard deviation in AQoL of 0.22, an expected ICC of 0.01 (calculated based on total primary care utilization over a one year period among a 10% sample of the Ontario population, which served here as a proxy measure for patient outcomes), and an expected attrition rate of 10% (rated based on previous studies in similar population groups using similar technology). A minimum sample size of 176 patients was calculated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge randomized trial. Group 1: 3 month control period followed by a 12 month intervention period. Group 2: 6 month control period followed by a 9 month intervention period.
| Arm | Type | Receives |
|---|---|---|
| ePRO Control (3 or 6 months) | No intervention | –Control participants will complete surveys at baseline, 3 months, and/or 6 months. Surveys will capture patient demographics, their assessment of quality-of-life, chronic disease management, and primary care experience. A part from completing these surveys, no change to routine care will be seen. |
| ePRO intervention (12 or 9 months) | Experimental | Device: ePRO Tool InterventionDuring the ePRO Tool intervention participants will complete surveys at every 3 months intervals starting month at 4 or month 7, for study duration. Surveys capture patient demographics, assessment of quality-of-life, chronic disease management, primary care experience, and Electronic Patient Reported Outcome (ePRO) Mobile Application tool usability. Participants will also meet with their provider to setup and monitor a health goal to track during the study via the ePRO application. During the study, participants will meet with their primary care providers 4-5 times to discuss their health goal monitoring. Post-study participants will discuss their experience using the ePRO app in an interview or focus group setting. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- a FHT patient at one of the FHT sites selected and is 60 years or older;
- physical capability to use a tablet and/or a caregiver who can use the tablet on their behalf;
- ability to read and write in English and/or the availability of a caregiver who can do so on their behalf;
- has complex care needs defined as two or more chronic conditions and 10 or more visits to their primary health care provider within the last 12 months; and
- be thinking about or ready to make changes to support their self-management.
Key exclusion criteria (1 listed)
- 1. Absence of Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePRO Tool InterventionAlso: Electronic Patient Reported Outcome Mobile Application, ePROThe ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal Tracker allows patients and providers to collaboratively create goal-oriented patient care-plans, and helps patients to track outcomes related to their goals using a mobile device. The Health Journal allows patients, their caregivers and primary care providers to monitor patients' symptoms and outcomes. | Device | ePRO intervention (12 or 9 months) |
Primary outcome
Change from baseline Assessment of Quality-of-Life at 3 month intervals for 15 months
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, and study end (15-months)
Our primary measure of patient oriented outcome is quality of life measured by the Assessment for Quality of Life Scale. 12 Item survey, with each item having 4 response levels.
6 secondary outcomes
ePRO cost-effectiveness - health system perspective
Time frame: 15-months
Patient Demographic and Characteristic information
Time frame: Baseline
Provider Demographic and Characteristic Information
Time frame: Baseline
Change from baseline Patient/Caregiver Self-Reported Costs at 3 month intervals for study duration (15 months)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, and study-end (15-months)
Change from baseline Patient Experience at 3 month intervals for study duration (15 months)
Time frame: Baseline, 3 months, 6 months, 9 months,12 months, and study-end (15-months)
Change from baseline Patient Activation Measure at 3 month intervals for study duration (15 months)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, and study-end (15-months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- BackgroundCommission on the Reform of Ontario's Public Services, Public Services for Ontarians: A Path to Sustainability and Excellence. 2012.
- Background: PubMed 14596756Reid R, Evans R, Barer M, Sheps S, Kerluke K, McGrail K, Hertzman C, Pagliccia N. Conspicuous consumption: characterizing high users of physician services in one Canadian province. J Health Serv Res Policy. 2003 Oct;8(4):215-24. doi: 10.1258/135581903322403281.
- Background: PubMed 16259671Heslop L, Athan D, Gardner B, Diers D, Poh BC. An analysis of high-cost users at an Australian public health service organization. Health Serv Manage Res. 2005 Nov;18(4):232-43. doi: 10.1258/095148405774518633.
- BackgroundDepartment of Health, Long Term Conditions Compedium of Information, Third Edition, D.o. Health, Editor. 2012: United Kingdom.
- Background: PubMed 22215161Emanuel EJ. Where are the health care cost savings? JAMA. 2012 Jan 4;307(1):39-40. doi: 10.1001/jama.2011.1927. No abstract available.
- Background: PubMed 25359294Rosella LC, Fitzpatrick T, Wodchis WP, Calzavara A, Manson H, Goel V. High-cost health care users in Ontario, Canada: demographic, socio-economic, and health status characteristics. BMC Health Serv Res. 2014 Oct 31;14:532. doi: 10.1186/s12913-014-0532-2.
- Background: PubMed 21402176Marengoni A, Angleman S, Melis R, Mangialasche F, Karp A, Garmen A, Meinow B, Fratiglioni L. Aging with multimorbidity: a systematic review of the literature. Ageing Res Rev. 2011 Sep;10(4):430-9. doi: 10.1016/j.arr.2011.03.003. Epub 2011 Mar 23.
- Background: PubMed 18083671Bayliss EA, Bosworth HB, Noel PH, Wolff JL, Damush TM, Mciver L. Supporting self-management for patients with complex medical needs: recommendations of a working group. Chronic Illn. 2007 Jun;3(2):167-75. doi: 10.1177/1742395307081501.
- Derived from this study: PubMed 36449335Tahsin F, Austin T, McKinstry B, Mercer SW, Loganathan M, Thavorn K, Upshur R, Steele Gray C. Examining Use Behavior of a Goal-Supporting mHealth App in Primary Care Among Patients With Multiple Chronic Conditions: Qualitative Descriptive Study. JMIR Hum Factors. 2022 Nov 30;9(4):e37684. doi: 10.2196/37684.
- Derived from this study: PubMed 35442194Miranda RN, Bhuiya AR, Thraya Z, Hancock-Howard R, Chan BC, Steele Gray C, Wodchis WP, Thavorn K. An Electronic Patient-Reported Outcomes Tool for Older Adults With Complex Chronic Conditions: Cost-Utility Analysis. JMIR Aging. 2022 Apr 20;5(2):e35075. doi: 10.2196/35075.
- Derived from this study: PubMed 34965860Singh H, Tahsin F, Nie JX, McKinstry B, Thavorn K, Upshur R, Harvey S, Wodchis WP, Gray CS. Exploring the perspectives of primary care providers on use of the electronic Patient Reported Outcomes tool to support goal-oriented care: a qualitative study. BMC Med Inform Decis Mak. 2021 Dec 29;21(1):366. doi: 10.1186/s12911-021-01734-0.
- Derived from this study: PubMed 34868614Tahsin F, Tracy S, Chau E, Harvey S, Loganathan M, McKinstry B, Mercer SW, Nie J, Ramsay T, Thavorn K, Palen T, Sritharan J, Steele Gray C. Exploring the relationship between the usability of a goal-oriented mobile health application and non-usage attrition in patients with multimorbidity: A blended data analysis approach. Digit Health. 2021 Oct 5;7:20552076211045579. doi: 10.1177/20552076211045579. eCollection 2021 Jan-Dec.
- ePRO Published Protocol DOI: 10.2196/resprot.5756 (PMID: 27341765)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The reported data (which includes patient information at the aggregate level) will be disseminated widely via reports, conference presentations, peer reviewed journal articles and other standard modes of knowledge translation.
Related trials for Chronic Disease
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Steele Gray, PhD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePRO Tool Intervention in people with Chronic Disease and Quality of Life, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Assessment of Quality-of-Life at 3 month intervals for 15 months (time frame: Baseline, 3 months, 6 months, 9 months, 12 months, and study end (15-months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917954, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.