Type 2 Diabetes MellitusNCT02158741
Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes
A study testing Home Visits and Lifestyle Education Support in people with Type 2 Diabetes Mellitus and NIDDM, run by McMaster University at 8 sites in Canada.
Trial summary
The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, NIDDM, Non-insulin Dependent Diabetes Mellitus
- What is being tested?
- Home Visits and Lifestyle Education Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 8 sitesCanada
- Study dates
- Sep 2014to May 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- older adults aged 65+
- live in the local vicinity of a participating Diabetes Education Program
- were referred to their Diabetes Education Program within the past 24 months
- competence in English (or access to a translator)
- intention to continue living in the area for the next 6 months
- two reported chronic conditions in addition to T2DM. Individuals with newly diagnosed T2DM as well as those who were already receiving treatment for T2DM will be eligible for inclusion in the study.
Who cannot join
- score of 20 or less in Montreal Cognitive Assessment (MoCA) test AND without access to a substitute decision maker to sign consent (Score of 20 or less is not in itself an exclusion).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Edmonton Oliver PCN
Edmonton, Alberta
McMaster University
Hamilton, Ontario, L8S 4K1
Leduc Beaumont Devon PCN
Leduc, Alberta, T9E 6W2
Ross Memorial Hospital
Lindsay, Ontario
St. Joseph's Health Care
London, Ontario
Peterborough Regional Health Centre
Peterborough, Ontario
Port Hope Community Health Centre
Port Hope, Ontario
Sherwood Park PCN
Sherwood Park, Alberta
About this study
Official title: A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions
The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers. Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.
Read the detailed description
Research Goal
To examine the comparative effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with T2DM and Multiple Chronic Conditions and their family caregivers.
Objectives
- To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services?
- To compare the effectiveness of the intervention on HRQoL, physical activity, nutritional status, depression, anxiety, diabetes parameters (blood glucose levels [HbA1c, hypoglycemic episodes]), diabetes-related complications, number of vascular events, social support number of falls, fall risk and medication safety with usual primary care services?
- To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care?
- To assess whether or not the intervention improves clinical practice behaviours?
- To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective?
- To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention?
- To determine the effectiveness of the intervention based on sex/gender and region?
- To determine the overall feasibility and acceptability of an IP community-based health promotion intervention and what can be identified as barriers and facilitators to implementation?
- Being tested
- Home Visits and Lifestyle Education Support
- Keywords
- Self-Management, Home Visits
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Visits and Lifestyle Education SupportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual Primary Care | No intervention | Usual Primary Care will be received by half the participants during the course of the Study |
| Home Visits and educational support | Active comparator | Intervention comprised of Home Visits and group educational sessions. Home Visits and will be conducted by Diabetes Education staff in lieu of usual care conducted at the Diabetes clinic. Lifestyle support and educational will be offered in the form of monthly Diabetes Wellness Days offered in the community where nutrition, exercise and support will be given to help improve self-management of diabetes. Receives: Behavioral: Home Visits and Lifestyle Education Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of Diabetes Self-Care Activities
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 items that assess the following aspects of the diabetes regimen: general and specific diet, exercise, blood-glucose testing, foot care, and smoking. Scores are calculated for each of these five regimen areas. This data is collected by the interventionists at each visit.
Measured: Every two months from study onset until the end of study (6 months from baseline)
Secondary outcomes (1)
SF12v2
This measurement is used to assess Health related quality of Life. This survey consists of 12 questions that measure functional health and well-being from the client's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health), and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores
Measured: Baseline and end of study (6 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Maureen Markle-Reid, McMaster University
- Investigators
- Maureen Markle-Reid, PhD, Principal investigator, McMaster UniversityJenny Ploeg, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158741
- Sponsor's protocol ID
- DRCT-06669
- Status last verified
- Aug 2019
- First submitted
- 3 Jun 2014
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Bartholomew A, Griffith LE, Miklavcic J, Gafni A, Thabane L, Upshur R. Community Program Improves Quality of Life and Self-Management in Older Adults with Diabetes Mellitus and Comorbidity. J Am Geriatr Soc. 2018 Feb;66(2):263-273. doi: 10.1111/jgs.15173. Epub 2017 Nov 27.
PubMed 29178317Miklavcic JJ, Fraser KD, Ploeg J, Markle-Reid M, Fisher K, Gafni A, Griffith LE, Hirst S, Sadowski CA, Thabane L, Triscott JAC, Upshur R. Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial. BMC Geriatr. 2020 May 13;20(1):174. doi: 10.1186/s12877-020-01557-0.
PubMed 32404059Markle-Reid M, Ploeg J, Valaitis R, Duggleby W, Fisher K, Fraser K, Ganann R, Griffith LE, Gruneir A, McAiney C, Williams A. Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. J Comorb. 2018 Jul 31;8(1):2235042X18789508. doi: 10.1177/2235042X18789508. eCollection 2018.
PubMed 30191144Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Akhtar-Danesh N, Bartholomew A, Gafni A, Gruneir A, Hirst SP, Kaasalainen S, Stradiotto CK, Miklavcic J, Rojas-Fernandez C, Sadowski CA, Thabane L, Triscott JA, Upshur R. The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):55. doi: 10.1186/s13063-017-1795-9.
PubMed 28166816
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions
- ClinicalTrials.gov ID
- NCT02158741
- Acronym / sponsor ID
- DRCT-06669
- Keywords
- Self-Management, Home Visits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 9 Jun 2014 (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.
The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers. Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.
Detailed description
Research Goal
To examine the comparative effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with T2DM and Multiple Chronic Conditions and their family caregivers.
Objectives
- To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services?
- To compare the effectiveness of the intervention on HRQoL, physical activity, nutritional status, depression, anxiety, diabetes parameters (blood glucose levels [HbA1c, hypoglycemic episodes]), diabetes-related complications, number of vascular events, social support number of falls, fall risk and medication safety with usual primary care services?
- To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care?
- To assess whether or not the intervention improves clinical practice behaviours?
- To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective?
- To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention?
- To determine the effectiveness of the intervention based on sex/gender and region?
- To determine the overall feasibility and acceptability of an IP community-based health promotion intervention and what can be identified as barriers and facilitators to implementation?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Primary Care | No intervention | –Usual Primary Care will be received by half the participants during the course of the Study |
| Home Visits and educational support | Active comparator | Behavioral: Home Visits and Lifestyle Education SupportIntervention comprised of Home Visits and group educational sessions. Home Visits and will be conducted by Diabetes Education staff in lieu of usual care conducted at the Diabetes clinic. Lifestyle support and educational will be offered in the form of monthly Diabetes Wellness Days offered in the community where nutrition, exercise and support will be given to help improve self-management of diabetes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- older adults aged 65+
- live in the local vicinity of a participating Diabetes Education Program
- were referred to their Diabetes Education Program within the past 24 months
- competence in English (or access to a translator)
- intention to continue living in the area for the next 6 months
Key exclusion criteria (1 listed)
- score of 20 or less in Montreal Cognitive Assessment (MoCA) test AND without access to a substitute decision maker to sign consent (Score of 20 or less is not in itself an exclusion).
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 |
|---|---|---|
| Home Visits and Lifestyle Education Support | Behavioural | Home Visits and educational support |
Primary outcome
Summary of Diabetes Self-Care Activities
Time frame: Every two months from study onset until the end of study (6 months from baseline)
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 items that assess the following aspects of the diabetes regimen: general and specific diet, exercise, blood-glucose testing, foot care, and smoking. Scores are calculated for each of these five regimen areas. This data is collected by the interventionists at each visit.
1 secondary outcome
SF12v2
Time frame: Baseline and end of study (6 months from baseline)
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 30 Aug 2019.
- Results publication: PubMed 29178317Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Bartholomew A, Griffith LE, Miklavcic J, Gafni A, Thabane L, Upshur R. Community Program Improves Quality of Life and Self-Management in Older Adults with Diabetes Mellitus and Comorbidity. J Am Geriatr Soc. 2018 Feb;66(2):263-273. doi: 10.1111/jgs.15173. Epub 2017 Nov 27.
- Derived from this study: PubMed 32404059Miklavcic JJ, Fraser KD, Ploeg J, Markle-Reid M, Fisher K, Gafni A, Griffith LE, Hirst S, Sadowski CA, Thabane L, Triscott JAC, Upshur R. Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial. BMC Geriatr. 2020 May 13;20(1):174. doi: 10.1186/s12877-020-01557-0.
- Derived from this study: PubMed 30191144Markle-Reid M, Ploeg J, Valaitis R, Duggleby W, Fisher K, Fraser K, Ganann R, Griffith LE, Gruneir A, McAiney C, Williams A. Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. J Comorb. 2018 Jul 31;8(1):2235042X18789508. doi: 10.1177/2235042X18789508. eCollection 2018.
- Derived from this study: PubMed 28166816Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Akhtar-Danesh N, Bartholomew A, Gafni A, Gruneir A, Hirst SP, Kaasalainen S, Stradiotto CK, Miklavcic J, Rojas-Fernandez C, Sadowski CA, Thabane L, Triscott JA, Upshur R. The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):55. doi: 10.1186/s13063-017-1795-9.
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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.
Maureen Markle-Reid, PhD principal investigator
McMaster University
Jenny Ploeg, PhD principal investigator
McMaster University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Visits and Lifestyle Education Support in people with Type 2 Diabetes Mellitus and NIDDM, run by McMaster University at 8 sites 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 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Summary of Diabetes Self-Care Activities (time frame: Every two months from study onset until the end of study (6 months from baseline)). 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 NCT02158741, which also lists 4 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 30 Aug 2019.