An interventional study of Integrated model of primary care in Frail Elderly Syndrome, sponsored by University of Waterloo. Completed at 3 sites in Canada. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-01.
Sponsored by University of Waterloo · Not applicable, Interventional, and Health services research
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Among 33 studies in Patient Participation with a site in Canada — 12 open to participants now, 13 under way, none of them phase 3. Patient Participation · Canada.
Among the 33 studies in Patient Participation with a site in Canada, this one is the 2nd largest by enrollment of the 26 interventional ones that give a count, is one of 2 that started in 2017, is one of 24 with no phase, and was the 6th registered.
409 studies on the registry are indexed under Patient Participation; 100 are open to participants now.
Browse Patient Participation studies →12 of the 33 studies in Patient Participation with a site in Canada are open now. Recruiting first, the newest first:
University Health Network, Toronto · Sites in Canada
Ages 18–80
University of Alberta · Sites in Canada
Ages 18+
University Health Network, Toronto · Sites in Canada
Ages 18–40
University of British Columbia · Sites in Canada
Ages 6 mo–18 yrs
University Health Network, Toronto · Sites in Canada
Ages 18+ · Women only
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 48 Patient Participation studies recruiting now, 32 (67%) set no upper age limit and 9 (19%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 70 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 695 is above the median of 128 across 322 interventional studies indexed under Patient Participation.
Median enrollment 149 across the 26 interventional studies, 75 across the 7 observational. Of the 16 that completed or were terminated, 2 (13%) have results posted.
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1 of 33 have an industry lead sponsor. The 10 most frequent:
University of Waterloo is the lead sponsor of 90 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.
University of Waterloo has 1 study filed under Patient Participation — fewer than ten, so there is no comparison to draw.
4 of the studies in Patient Participation with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07686133University Health Network, TorontoDigital Education in Colorectal Cancer Patients | 2027-01 |
| NCT05371548Robyn TamblynSmart About Meds (SAM) RCT | 2027-03 |
| NCT07831837Laval UniversityEvaluation and Implementation of Digital Health Ecosystem in Academic Health Center | 2027-05-01 |
| NCT07818980University Health Network, TorontoCo-Adaptation of an Digital Pain Management Program for Canadian Veterans | 2027-09 |
Add all 4 to your calendar (.ics) → With an account.
Among the 33 studies in Patient Participation with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
It is well known that older Canadians are high users of health care services. What is less well known is that the health care system is not well-designed to meet the needs of those who use it most. Older persons look to their primary care practitioners to assess their needs and coordinate their care. Unfortunately, the health concerns of older persons are often missed in too-short office visits. They may need care from a variety of providers and services, but this care is often not well-coordinated. Older persons and their caregivers are the experts in their own needs and preferences, but often do not have a chance to participate fully in treatment decisions or care planning. As a result, they may have health problems that are not properly assessed, managed or treated resulting in poorer health, as well as preventable and expensive emergency department visits and hospital stays.
Improving the health of older Canadians means identifying health problems early. It means providing timely supports so that manageable concerns do not spiral out of control. And, above all, it means helping health care providers actively engage older patients and their family caregivers as partners in care. Patients want to make informed choices about their health and the care they receive, based on their personal values, preferences and goals, and informed by available evidence.
Nine primary care clinics in three provinces (Quebec, Ontario, Alberta) will use a quick screening tool to identify older patients who are at risk of becoming frail. This will help initiate referral to health care or support services where necessary. Innovative technology will be used to streamline the referral process and help assist older adults in decision-making about their care.
With support from the Canadian Frailty Network (CFN, formerly TVN), researchers, collaborators, health care providers and older adults from across Canada will work together to transform primary health care for frail elderly Canadians.
The team will be implementing evidence-based and tested interventions as a coherent strategy to enhance primary health care for older adults, working collaboratively with study sites, older adults, and other stakeholders to develop a scalable and sustainable model. The investigators aim to develop the capacity of primary health care teams to identify, assess, and support older adults (70+) who are frail, and to delay or prevent decline for those at lower risk. The project will support patient/caregiver engagement, and stronger care coordination and integration with other health and social services. The primary research question is: compared to usual care in primary care settings, does the proposed model improve health, social and economic outcomes for frail and at-risk older Canadians (aged 70+)? The investigators hypothesize that older adults will benefit from screening, active engagement in care planning, and appropriate referrals to services earlier in their care trajectories. In addition to improving health outcomes and quality of life for patients, more proactive interventions can reduce costly emergency department visits and unplanned hospital admissions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Integrated model of primary care
Other: Integrated model of primary care
Intervention includes: 1) consistent risk screening and assessment; 2) care coordination and system navigation; 3) patient/caregiver engagement and shared decision-making; and 4) enabling technology supports.
Assessing change in 'Care for Chronic Conditions' scores
This tools measures specific items related to the Chronic Care Model, and reports on patient experience with the system. There are 5 sub scales (patient activation, delivery system, goal setting, problem solving and coordination) and 26-items. This tool has been validated.
Time frame: The tool will be used at 4 time points: at baseline recruitment (B1), then 6 months later (B2), then 6 months later following intervention implementation (I1), and 6 months later (I2). Scores will be compared pre and post.
Assessing change in 5-Level EQ-5D questionnaire
This tool measures health-related quality of life. The tool is comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Time frame: The tool will be used at 4 time points: at baseline recruitment (B1), then 6 months later (B2), then 6 months later following intervention implementation (I1), and 6 months later (I2). Scores will be compared pre and post.
Assessing change in the Canadian Institute for Health Information Primary Care Provider Survey
This survey addresses team function, involvement in governance, use of information technology and scope of practice.
Time frame: This tool will be used at two time points. Once at baseline (B1) and again at the end of the study (2.5 years later) post implementation (I2). All providers involved in the work will completed the tool.
Assessing Healthcare Utilization across different time points
Self-reported health care utilization data including hospital admissions; emergency department visits, home care services; specialist visits and primary care visits.
Time frame: The tool will be used at 4 time points: at baseline recruitment (B1), then 6 months later (B2), then 6 months later following intervention implementation (I1), and 6 months later (I2). Scores will be compared pre and post.
Assessing change in Goal Attainment Scaling (GAS)
GAS is an individualized, client-centred goal-setting and measurement approach that can accommodate a client's individual wishes, values and preferences. Goals are scaled on a five-point rating scale from -2 (much less than expected) to +2 (much better than expected). The GAS formula translates the total GAS score into a standardized score, with a score of 50 representing overall goal attainment.
Time frame: GAS will be completed with a small sub-set of participants during qualitative interviews at baseline recruitment (B1), then 6 months later (B2), then 6 months later following intervention implementation (I1), and 6 months later (I2).
Assessing change in Canadian Institute for Health Information Primary Care Organizational Survey
This survey is usually completed by a manager or director of the primary care site. The survey covers many domains such as human resources, accessibility, coordination, quality improvement, and system integration.
Time frame: This tool will be used at two time points. Once at baseline (B1) and again at the end of the study (2.5 years later) post implementation (I2).All providers involved in the work will completed the tool.
Plan to share: No
Ran from Nov 2017 to primary completion in Dec 2020, 37 months.
Of 219 non-industry interventional studies with no phase under Patient Participation, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 37 months is above that.
Counting every sponsor, half of 226 studies reached it within 20 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Waterloo