Type 2 DiabetesNCT04607915
Technology-enabled Collaborative Care for Diabetes Management During COVID-19
A study testing Intervention for TECC Model in people with Type 2 Diabetes, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for type 2 diabetes designed to support patients with diabetes and mental… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intervention for TECC Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2021to 30 Jun 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 years and older
- Clinician diagnosis of Type 2 diabetes for at least one year
- A1C level of 7.5% or higher within the last 6 months (benchmark is 7%)
- Access to telephone or internet through computer or mobile
- Experiencing some distress, score of ** on Perceived Stress Scale
Who cannot join
- Unable to provide consent
- Unable to understand English
- Pregnant or planning to get pregnant during the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology-enabled Collaborative Care for Diabetes (TECC-Diabetes) Management During COVID: A Feasibility Study
The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for type 2 diabetes designed to support patients with diabetes and mental health concerns during COVID-19.
Read the detailed description
There is growing concern regarding the impact of COVID-19 and social isolation on mental health and wellbeing, particularly adults living with type 2 diabetes (T2DM), who are at greater risk for mental health issues than the general population. Self-management education and support for healthy eating, physical activity, glucose monitoring, medication adherence and problem solving are vital components of diabetes care. Due to social distancing and limited care and resources, that are likely to persist in the post pandemic phase other innovative service models should be developed and adopted to improve service delivery. The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for T2DM designed to support patients with diabetes and mental health concerns during COVID-19.
- Conditions
- Type 2 Diabetes
- Being tested
- Intervention for TECC Model
- 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.
Intervention for TECC ModelBehavioural
The Care Coordinator (CC) will provide brief coaching sessions (15 to 20 minutes) to each participant once per week for 8 weeks. Participants can identify topics for discussion and the CC and participant can decide if a video session via WebEx is required versus a phone call. Also, participants will be given peer support and will be indirectly monitored by a virtual care team of experts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention for TECC Model | Experimental | Not described Receives: Behavioral: Intervention for TECC Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment Numbers
The primary outcome in this study is feasibility, specifically process outcomes. This includes assessing recruitment number
Measured: Through the study completion, an average of 4 months
Feasibility - Participant characteristics
The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics
Measured: up to 8-weeks
Feasibility - Participant Engagement (retention rate)
The primary outcome in this study is feasibility, specifically process outcomes. This includes participant retention rate (e.g., defined by time between first and last visit)
Measured: up to 8-weeks
Feasibility - Participant Engagement (intensity)
The primary outcome in this study is feasibility, specifically process outcomes. This includes intensity (e.g., number of session participants attend)
Measured: up to 8-weeks
Feasibility - Participant Engagement (drop out)
The primary outcome in this study is feasibility, specifically process outcomes. This includes drop out (consented/enrolled but did not attend first one-on-one)
Measured: up to 8-weeks
Feasibility - Delivery of Intervention (Time with coach)
The primary outcome in this study is feasibility, specifically process outcomes. This includes the amount of time a coach spends per interaction
Measured: up to 8-weeks
Feasibility - Delivery of Intervention (Mode of interaction)
The primary outcome in this study is feasibility, specifically process outcomes. This includes the mode of the interaction (i.e., virtual, telephone or both)
Measured: up to 12-weeks
Feasibility - Delivery of Intervention (Coach strategies)
The primary outcome in this study is feasibility, specifically process outcomes. This includes what strategies are used by the coach (i.e., educational, psychosocial support, behaviour modifications, or case management/monitoring)
Measured: up to 12-weeks
Secondary outcomes (3)
Study Participant experience and satisfaction via semi-structured interview
The secondary outcome consists of study participant experience/satisfaction.
Measured: up to 8-weeks
Care Coordinator experience and satisfaction via semi-structured interview
The secondary outcome consists of Care Coordinator experience and satisfaction.
Measured: up to 8-weeks
Virtual Care Team experience and satisfaction via semi-structured interview
The secondary outcome consists of Virtual Care Team experience and satisfaction.
Measured: up to 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start4 May 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Selby, Centre for Addiction and Mental Health
- Investigators
- Peter Selby, Principal investigator, CAMHDiana Sherifali, Principal investigator, McMaster UniversityFarooq Naeem, Principal investigator, CAMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607915
- Sponsor's protocol ID
- 104-2020
- Status last verified
- Feb 2023
- First submitted
- 30 Jul 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vojtila L, Sherifali D, Dragonetti R, Ashfaq I, Veldhuizen S, Naeem F, Agarwal SM, Melamed OC, Crawford A, Gerretsen P, Hahn M, Hill S, Kidd S, Mulsant B, Serhal E, Tackaberry-Giddens L, Whitmore C, Marttila J, Tang F, Ramdass S, Lourido G, Sockalingam S, Selby P. Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2023 Jan 17;12:e39724. doi: 10.2196/39724.
PubMed 36649068
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-enabled Collaborative Care for Diabetes (TECC-Diabetes) Management During COVID: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04607915
- Acronym / sponsor ID
- 104-2020
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Oct 2020 (actual)
- 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 goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for type 2 diabetes designed to support patients with diabetes and mental health concerns during COVID-19.
Detailed description
There is growing concern regarding the impact of COVID-19 and social isolation on mental health and wellbeing, particularly adults living with type 2 diabetes (T2DM), who are at greater risk for mental health issues than the general population. Self-management education and support for healthy eating, physical activity, glucose monitoring, medication adherence and problem solving are vital components of diabetes care. Due to social distancing and limited care and resources, that are likely to persist in the post pandemic phase other innovative service models should be developed and adopted to improve service delivery. The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for T2DM designed to support patients with diabetes and mental health concerns during COVID-19.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention for TECC Model | Experimental | Behavioral: Intervention for TECC Model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 years and older
- Clinician diagnosis of Type 2 diabetes for at least one year
- A1C level of 7.5% or higher within the last 6 months (benchmark is 7%)
- Access to telephone or internet through computer or mobile
- Experiencing some distress, score of ** on Perceived Stress Scale
Key exclusion criteria (3 listed)
- Unable to provide consent
- Unable to understand English
- Pregnant or planning to get pregnant during the course of the study
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 |
|---|---|---|
| Intervention for TECC ModelThe Care Coordinator (CC) will provide brief coaching sessions (15 to 20 minutes) to each participant once per week for 8 weeks. Participants can identify topics for discussion and the CC and participant can decide if a video session via WebEx is required versus a phone call. Also, participants will be given peer support and will be indirectly monitored by a virtual care team of experts. | Behavioural | Intervention for TECC Model |
Primary outcome
Feasibility - Recruitment Numbers
Time frame: Through the study completion, an average of 4 months
The primary outcome in this study is feasibility, specifically process outcomes. This includes assessing recruitment number
Feasibility - Participant characteristics
Time frame: up to 8-weeks
The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics
Feasibility - Participant Engagement (retention rate)
Time frame: up to 8-weeks
The primary outcome in this study is feasibility, specifically process outcomes. This includes participant retention rate (e.g., defined by time between first and last visit)
Feasibility - Participant Engagement (intensity)
Time frame: up to 8-weeks
The primary outcome in this study is feasibility, specifically process outcomes. This includes intensity (e.g., number of session participants attend)
Feasibility - Participant Engagement (drop out)
Time frame: up to 8-weeks
The primary outcome in this study is feasibility, specifically process outcomes. This includes drop out (consented/enrolled but did not attend first one-on-one)
Feasibility - Delivery of Intervention (Time with coach)
Time frame: up to 8-weeks
The primary outcome in this study is feasibility, specifically process outcomes. This includes the amount of time a coach spends per interaction
Feasibility - Delivery of Intervention (Mode of interaction)
Time frame: up to 12-weeks
The primary outcome in this study is feasibility, specifically process outcomes. This includes the mode of the interaction (i.e., virtual, telephone or both)
Feasibility - Delivery of Intervention (Coach strategies)
Time frame: up to 12-weeks
The primary outcome in this study is feasibility, specifically process outcomes. This includes what strategies are used by the coach (i.e., educational, psychosocial support, behaviour modifications, or case management/monitoring)
3 secondary outcomes
Study Participant experience and satisfaction via semi-structured interview
Time frame: up to 8-weeks
Care Coordinator experience and satisfaction via semi-structured interview
Time frame: up to 8-weeks
Virtual Care Team experience and satisfaction via semi-structured interview
Time frame: up to 8-weeks
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 10 Feb 2023.
- Derived from this study: PubMed 36649068Vojtila L, Sherifali D, Dragonetti R, Ashfaq I, Veldhuizen S, Naeem F, Agarwal SM, Melamed OC, Crawford A, Gerretsen P, Hahn M, Hill S, Kidd S, Mulsant B, Serhal E, Tackaberry-Giddens L, Whitmore C, Marttila J, Tang F, Ramdass S, Lourido G, Sockalingam S, Selby P. Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2023 Jan 17;12:e39724. doi: 10.2196/39724.
Related trials for Type 2 Diabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
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.
Peter Selby principal investigator
CAMH
Diana Sherifali principal investigator
McMaster University
Farooq Naeem principal investigator
CAMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention for TECC Model in people with Type 2 Diabetes, run by Centre for Addiction and Mental Health at 1 site 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 5 inclusion and 3 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Feasibility - Recruitment Numbers (time frame: Through the study completion, an average of 4 months). The study lists 8 primary outcomes in all. 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 NCT04607915, which also lists 1 linked publication.
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 10 Feb 2023.