Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04030364
Status:
UNKNOWN
Last Update Posted:
2019-09-06
First Post:
2019-07-05
Brief Title:
Implementation of a Multi-component Supervised Exercise Program for Patients With Type 2 Diabetes Mellitus
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Implementation of a Multi-component Supervised Exercise Program for Patients With Type 2 Diabetes Mellitus From a Primary Care Practice A Quality Improvement Study
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This quality improvement study aims to implement a supervised multi-component exercise program for patients type 2 diabetes mellitus T2DM from a primary care practice Rosemount Clinic patients with T2DM will be invited to participate in free group exercise classes as part of a 3-month program of structured exercise to enhance adherence to the Canadian Diabetes Association CDA clinical best practice guidelines Interested patients will attend an initial 1-hour information session and then will complete short monthly questionnaires about their current quality of life and experience with the exercise program Participation is voluntary and patients may drop out at any time
Detailed Description:
The Canadian Diabetes Association 2018 Clinical Practice Guidelines state that moderate to high levels of physical activity and cardiorespiratory fitness are associated with substantially lower morbidity and mortality in people with diabetes The recommendations include a combination of aerobic resistance and flexibility exercises The Guidelines specifically advocate for strategies that increase self-efficacy and motivation in order to increase physical activity uptake and maintenance
Similarly the importance of exercise counselling in primary care is widely recognized Exercise is frequently identified as a key intervention for many chronic conditions yet it remains under-prescribed Physical activity counselling during routine diabetes care often takes a back seat to other issues or lacks specific actionable details that are important for patients to successfully integrate regular physical activity into their lifestyle Moreover even when prescribed the successful implementation of physical activity behaviour changes remains a challenge for patients
Eligible Rosemount Family Health Organization adult patients age 18 years with type 2 diabetes mellitus will receive an email or mail invitation to self-refer to a structured facility-based supervised aerobic and resistance exercise program Interested patients will be invited to attend a 1-hour information session at the exercise facility at the time of implementation start up where they will complete an initial survey Patients will then be free to attend up to 6 regularly-scheduled group free classes per week at a local exercise facility for a period of 3-months Classes will be supervised by experienced trainers
Measures of program success will focus around four themes informed in part by the Institute for Healthcare Improvements Triple Aim i adherence to CDA guidelines for physical activity ii patient experience and iii health impact Our balancing measure will be potential costs incurred by patients Adherence measures including percentage uptake ie attend introductory session and one class retention at 1 2 and 3-months and percentage who meet CDA recommendations for exercise will be collected Reasons for declined or discontinued participation will also be collected voluntarily from patients to help identify concrete or perceived barriers to structured exercise programs Health-related measures will include quality of life EQ-5D-5L and exercise self-efficacy Basic Psychological Needs in Exercise Scale BP-NES These will be measured by patient-report at 0 1 2 and 3-months Participants will be asked to rate their willingness to recommend Likert scale 1-10 the program to other individuals with T2DM Additionally pre- and post-exercise program hemoglobin A1c and blood pressure measurements both of which are routinely collected for all patients with T2DM will be obtained from patient charts Finally while this program will be free to patients a hypothetical cost per patient will be estimated in order to gain an understanding of the financial costs compared to the value added through patient experience and health outcome measures
Similarly the importance of exercise counselling in primary care is widely recognized Exercise is frequently identified as a key intervention for many chronic conditions yet it remains under-prescribed Physical activity counselling during routine diabetes care often takes a back seat to other issues or lacks specific actionable details that are important for patients to successfully integrate regular physical activity into their lifestyle Moreover even when prescribed the successful implementation of physical activity behaviour changes remains a challenge for patients
Eligible Rosemount Family Health Organization adult patients age 18 years with type 2 diabetes mellitus will receive an email or mail invitation to self-refer to a structured facility-based supervised aerobic and resistance exercise program Interested patients will be invited to attend a 1-hour information session at the exercise facility at the time of implementation start up where they will complete an initial survey Patients will then be free to attend up to 6 regularly-scheduled group free classes per week at a local exercise facility for a period of 3-months Classes will be supervised by experienced trainers
Measures of program success will focus around four themes informed in part by the Institute for Healthcare Improvements Triple Aim i adherence to CDA guidelines for physical activity ii patient experience and iii health impact Our balancing measure will be potential costs incurred by patients Adherence measures including percentage uptake ie attend introductory session and one class retention at 1 2 and 3-months and percentage who meet CDA recommendations for exercise will be collected Reasons for declined or discontinued participation will also be collected voluntarily from patients to help identify concrete or perceived barriers to structured exercise programs Health-related measures will include quality of life EQ-5D-5L and exercise self-efficacy Basic Psychological Needs in Exercise Scale BP-NES These will be measured by patient-report at 0 1 2 and 3-months Participants will be asked to rate their willingness to recommend Likert scale 1-10 the program to other individuals with T2DM Additionally pre- and post-exercise program hemoglobin A1c and blood pressure measurements both of which are routinely collected for all patients with T2DM will be obtained from patient charts Finally while this program will be free to patients a hypothetical cost per patient will be estimated in order to gain an understanding of the financial costs compared to the value added through patient experience and health outcome measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None