Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Mental Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Mental Component Summary score. |
The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess mental health. The tool consists of 12 questions that measure functional health and well-being from the participant's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, mental health), by which a psychometrically-based Physical Component Summary (PCS) and Mental Component Summary (MCS) can be calculated. Response options include the frequency of feeling a certain way or behaviour across 3 or 5 categories (e.g., 'all of the time'...'none of the time'). Patients and caregivers will be evaluated for change in SF-12-MCS from baseline to 6-months. Total scale range: 0 - 100. Higher scores represent better mental functioning. |
Baseline, 6-months |
|
| Secondary |
Self-Management Using the Summary of Diabetes Self-Care Activities (SDSCA) |
The Summary of Diabetes Self-Care Activities (SDSCA) will be used to assess self-management. The SDSCA is a multidimensional measure of diabetes self-management with adequate internal and test-retest reliability, and evidence of validity and sensitivity to change. The revised SDSCA consists of 11 items that assess the following aspects of the diabetes regimen: (1) general and specific diet; (2) exercise; (3) blood-glucose testing; (4) foot care; and (5) smoking. Change in patient self-management will be evaluated using the SDSCA. Scale range: 0 - 71. Higher scores represent better self-management. |
Baseline, 6-months |
|
| Secondary |
Physical Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Physical Component Summary score. |
The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess physical health. The tool consists of 12 questions that measure functional health and well-being from the participant's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, mental health) by which a psychometrically-based Physical Component Summary (PCS) and Mental Component Summary (MCS) score can be calculated. Response options include the frequency of feeling a certain way or behaviour across 3 or 5 categories (e.g., 'all of the time'...'none of the time'). Patients and caregivers will be evaluated for change in SF-12-PCS from baseline to 6-months. Total scale range: 0 - 100. Higher scores represent better physical functioning. |
Baseline, 6-months |
|
| Secondary |
Depressive Symptoms Using the Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10) |
The Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10) will be used to assess depressive symptoms. This tool has been used in prior studies of older adults with mood disorders, has a high degree of reliability and validity, and is a sensitive tool for measuring changes in depressive symptoms over time. Participants will be asked about the way they have felt or behaved in response to 10 statements such as 'I was happy'. Response options ask participants to select the frequency they have felt or behaved during the last week, ranging from 'rarely or none of the time (less than 1 day)', 'some or a little of the time (1-2 days)', 'occasionally or moderate (3-4 days)', to 'most or all of the time (5-7 days)'. Patients and caregivers will be evaluated for change in depressive symptoms using CES-D-10. Scale range: 0 - 30. Higher scores represent more depressive symptoms. |
Baseline, 6-months |
|
| Secondary |
Level of Anxiety Using the Generalized Anxiety Disorder 7-Item (GAD-7) |
The Generalized Anxiety Disorder 7-Item (GAD-7) will be used to assess anxiety levels. The GAD-7 is a 7-item tool that asks about the type and frequency of being bothered by a list of problems. Response options include 'not at all', 'several days', 'more than half the days', or 'nearly every day', over the last two weeks. Patients and caregivers will be evaluated for change in level of anxiety using GAD-7. Scale range: 0 - 21. Higher scores represent more anxiety. |
Baseline, 6-months |
|
| Secondary |
Physical Activity Using the Physical Activity Scale for the Elderly (PASE) |
The Physical Activity Scale for the Elderly (PASE) tool will be used to assess the physical activity of patients. The PASE measures physical activity over the past 7 days. It asks about the type and frequency of physical activity across categories of light, moderate and strenuous physical activity. Patients will be evaluated for change in physical activity using the PASE tool. Higher scores represent better physical activity. |
Baseline, 6-months |
|
| Secondary |
Caregiver Strain Using the Modified Caregiver Strain Index (MCSI) |
The Modified Caregiver Strain Index (MCSI) will be used to assess caregiver strain. This tool will ask caregivers a list of 13 activities that they may have found to be difficult such as sleeping, physical strain, financial strain, personal plans, and work and family adjustments as a result of the caregiver role. Response options include 'yes' according to two levels, either 'yes, on a regular basis' or 'yes, sometimes', or alternatively, 'no'. Scale range: 0 - 26. Higher scores represent more strain. |
Baseline, 6-months |
|
| Secondary |
Social Support Using the Abbreviated Duke Social Support Index (DSSI) |
The abbreviated, 11-item Duke Social Support Index (DSSI) will be used to measure social support. This 11-item instrument includes two major sub-scales: a 4-item social interaction sub-scale and a 7-item subjective support sub-scale. Response options on the social interaction sub-scale ask participants to rate the frequency of their social interactions in the past week: "none", "1-2", ">2", or "0-1 time", "2-5 times", "6 or more times". Response options on the subjective support sub-scale include "hardly ever", "some of the time", "most of the time", or "very dissatisfied", "somewhat dissatisfied" "satisfied". Scale range: 11-33. Higher DSSI scores represent more social support. |
Baseline, 6-months |
|
| Secondary |
Functional Status Using the Duke Older Americans Resources and Services Procedures (OARS) Multidimensional Functional Assessment Questionnaire - Activities of Daily Living section |
The OARS Multidimensional Functional Assessment Questionnaire is a valid and reliable questionnaire, designed to assess the overall personal functional status and service use of older adults. Participants will be asked to respond to questions from the Activities of Daily Living section [14-items; activities of daily living (ADLs)/instrumental activities of daily living (IADLs)] of the OARS, which assesses both activities of daily living, such as eating, dressing and walking; and instrumental activities of daily living, such as using a telephone, shopping for groceries, and preparing meals. Response options include "without help", "with some help", and "completely unable". Scale range: 0-28. Higher scores represent a higher level of function. |
Baseline, 6-months |
|
| Secondary |
Nutritional Status Using the Seniors in the Community Risk Evaluation for Eating and Nutrition tool (SCREEN II-AB) |
The Seniors in the Community Risk Evaluation for Eating and Nutrition tool (SCREEN II-AB) is an abbreviated, 8-item nutrition screening instrument for older adults living in the community, to identify individuals at risk for nutritional problems or who have poor nutritional status. Items assess for weight change in the past 6 months, intake of fruit, vegetables and fluid, meal consumption and preparation, appetite, and swallowing. Scale range: 0-52. Higher scores represent lower risk for nutritional problems. |
Baseline, 6-months |
|
| Secondary |
Shared Decision-Making Using the CollaboRATE tool |
The CollaboRATE tool consists of 3 items that measure the level of shared decision-making in a clinical encounter from the patient's perspective. These items are: (i) How much effort was made to help you understand your health issues? (ii) How much effort was made to listen to what matters most to you about your health issues? (iii) How much effort was made to include what matters most to you in choosing what to do next? Participants are asked to rate their last appointment, on a 10-point scale from 0=No effort was made, to 9=Every effort was made. Scale range: 0-27. Higher scores represent a higher degree of shared decision-making. |
Baseline, 6-months |
|
| Secondary |
Service Use Using the Health and Social Services Utilization Inventory (HSSUI) |
The Health and Social Services Utilization Inventory (HSSUI) will be used to assess service use of patients and caregivers. The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services from a societal perspective. The HSSUI provides information on different categories of use including acute care service use such as emergency department visits and hospitalizations, use of nursing and allied health professionals, and visits to family doctors and specialists. As part of the HSSUI, diabetes and other medications, supplies and devices will also be assessed. Change in the use of health and social services will be assessed for patients and caregivers using the HSSUI. Patients (not caregivers) will be assessed for medication use using the HSSUI. |
Baseline, 6-months |
|
| Secondary |
Glycated hemoglobin (HbA1c) |
Patients will be evaluated for glycated hemoglobin (HbA1c) as abstracted from their medical records. Values closest to the time frame will be used. |
Baseline, 6-months |
|
| Secondary |
Glomerular Filtration Rate (GFR) |
Patients will be evaluated for glomerular filtration rate (GFR) as abstracted from their medical records. Values closest to the time frame will be used. |
Baseline, 6-months |
|
| Secondary |
Low-Density Lipoprotein (LDL) |
Patients will be evaluated for low-density lipoprotein (LDL) as abstracted from their medical records. Values closest to the time frame will be used. |
Baseline, 6-months |
|
| Secondary |
Collaboration Using the Partnership Self-Assessment Tool (PSAT) |
The Partnership Self-Assessment (PSAT) will be used to assess the collaboration process. The PSAT tool has shown acceptable validity and reliability. Questions ask about different aspects of the partnership, and the strengths and weaknesses of the collaboration process involved in the partnership (e.g., synergy, leadership, efficiency, administration and management etc.). Providers and managers will be evaluated for change in collaboration. Scale range: 1 - 5. Lower scores represent a lower level of collaboration. |
6-months |
|
