Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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27 March 2023 |
Main ID: |
NCT02742597 |
Date of registration:
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21/03/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Patient-Centred Innovations for Persons With Multimorbidity - Ontario
PACEinMM-ON |
Scientific title:
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Patient-Centred Innovations for Persons With Multimorbidity - Ontario |
Date of first enrolment:
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January 12, 2016 |
Target sample size:
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175 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02742597 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Moira Stewart |
Address:
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Telephone:
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Email:
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Affiliation:
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Western University |
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Key inclusion & exclusion criteria
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For Quantitative (Study 2.2):
Inclusion Criteria for Patients:
- 3+ Chronic Conditions
- 18 to 80 years of age
- Eligible for TIP/IMPACT Plus program
- Must live in catchment area for TIP/IMPACT Plus program (Toronto, Ontario, Canada)
Exclusion Criteria for Patients:
- Unable to reasonably respond to questionnaires or provide informed consent (ie.
cognitive impairment or language barrier)
- Deemed by provider to be too fragile
For Qualitative (Study 2.1):
Inclusion Criteria:
- Decision Makers: Responsible for policy and financial decisions related to the TIP /
IMPACT Plus program
- TIP / IMPACT Providers: Providers that have delivered the TIP / IMPACT Plus
intervention to at least one patient, including pharmacist, nurse, nurse practitioner,
physiotherapist, social worker, dietitian, occupational therapist, personal care
worker / home care coordinator
- Family Physicians / Specialists: Those that take part in the TIP / IMPACT Plus
intervention, including internist, psychiatrist, and family physician
- Patients: Need to meet the inclusion criteria of the TIP / IMPACT Plus program, 18 to
80 years of age, 3+ chronic conditions, and have received the intervention a minimum
of 4 months prior to the qualitative interview
- Family and Caregivers: Need to be a family member or caregiver of a TIP / IMPACT Plus
patient that has received the intervention a minimum of 4 months prior to the
qualitative interview.
- Referral Provider: Emergency Department doctor, nurse practitioner, CCAC coordinator
or representative community family doctor that has referred patients to the TIP /
IMPACT Plus program.
Exclusion criteria:
- Decision Makers that are not knowledgeable about or involved with the TIP / IMPACT
Plus program
- Providers/Family Physicians/Specialists that have not ever referred to or taken part
in a TIP / IMPACT Plus intervention or have not been active with the program in the
last year
- Family and Caregivers of Patients or Patients themselves that haven't yet received the
TIP / IMPACT Plus intervention or those that received the intervention within the last
4 months
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arthritis
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Cancer
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Chronic Bronchitis
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Crohn's Disease
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Diabetes
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Multimorbidity
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Osteoporosis
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Chronic Hepatitis
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Gastroesophageal Reflux
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Kidney Disease
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Stroke
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Urinary Tract Problem
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Dementia
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Diverticulosis
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Thyroid Disorder
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HIV
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Hypertension
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Irritable Bowel
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Transient Ischemic Attacks
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Ulcerative Colitis
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Rheumatoid Arthritis
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Asthma
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Cardiovascular Disease
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Hyperlipidemia
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Alzheimer's Disease
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Anxiety
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Chronic Obstructive Pulmonary Disease (COPD)
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Depression
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Ulcer
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Heart Failure
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Musculoskeletal Pain
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Intervention(s)
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Behavioral: TIP / IMPACT Plus Care Coordination
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Primary Outcome(s)
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Evaluation of Intervention Effectiveness - Change in Self-Management outcomes
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Evaluation of Intervention Effectiveness - Change in Self-Efficacy
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Evaluation of Intervention Effectiveness - Change in Patient-Centredness
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Evaluation of Intervention Effectiveness - Change in Transitions of Care
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Secondary Outcome(s)
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Evaluation of Intervention Effectiveness - Change in Psychological Well-being
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Evaluation of Intervention Effectiveness - Change in Quality of Life
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Evaluation of Intervention Effectiveness - Change in Demographics
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Evaluation of Intervention Effectiveness - Change in Equity
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Evaluation of Intervention Effectiveness - Change in Health Status
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Evaluation of Intervention Effectiveness - Change in Lifestyle/Health Behaviours
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Evaluation of Intervention Effectiveness - Change in Chronic Diseases
[Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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