Diabetes Mellitus, Type 2NCT01880476
Interprofessional Community-Based Diabetes Intervention for Older Adults
A study testing Home visits and group program in people with Diabetes Mellitus, Type 2, run by McMaster University at 1 site in Canada.
Trial summary
This study will examine the feasibility and acceptability of a 6-month interprofessional community-based health promotion program, and explore its effects on older adults' self-management of Type 2 Diabetes (T2DM). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Home visits and group program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Dec 2015
- 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
- Age 65+
- Referred to Diabetes Care Guelph within the past 12 months
- At least two chronic conditions in addition to Type 2 Diabetes Mellitus
- English speaking
- Community-dwelling, in the city of Guelph
- Independent in activities of daily living
- Mentally competent to provide informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability and Effects of an Interprofessional Community-Based Health Promotion Intervention on Self-Management in Older Adults With Type 2 Diabetes and Comorbid Chronic Conditions: A Pilot Study
This study will examine the feasibility and acceptability of a 6-month interprofessional community-based health promotion program, and explore its effects on older adults' self-management of Type 2 Diabetes (T2DM). Recently enrolled clients of Diabetes Care Guelph (DCG), who are age 65+ and have at least two other chronic conditions, will be eligible to participate. Participants must be English speaking, community-dwelling, independent in activities of daily living, and mentally competent to give informed consent. The 6-month intervention will consist of: in-home visits by a Registered Nurse and Registered Dietitian from DCG; participation in a monthly Diabetes Wellness Day group program offered through the Guelph Wellington Seniors Association (GWSA) together with DCG; peer support from trained volunteers at the Diabetes Wellness Day group program; care coordination by the DCG Registered Nurse to help participants access necessary supports and services; and monthly team conferences between care providers at DCG and the GWSA to develop a client-centred plan of care. To evaluate the program, participants will complete interviewer-administered questionnaires before and after the intervention, and care providers and peer volunteers will take part in group interviews.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Home visits and group program
- Keywords
- Diabetes Mellitus, Type 2, Comorbidity, Aged, Health Services
- 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 group programOther
Participants will receive up to three home visits by a Registered Nurse and two home visits by a Registered Dietitian over the 6-month intervention period. Participants will also be invited to attend a monthly Diabetes Wellness Day group program which will include diabetes education, interaction with peer volunteers, group exercise, and a meal. The Registered Nurse will coordinate care to help participants access necessary community supports and services and lead monthly interprofessional case conferences to develop a client-centred plan of care for each study participant.
| Study group | Role | What they receive |
|---|---|---|
| Home visits and group program | Experimental | Not described Receives: Other: Home visits and group program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in the Summary of Diabetes Self-Care Activities questionnaire
This questionnaire measures self-care activities including diet, exercise, blood glucose testing, foot care, and smoking.
Measured: baseline and 6 months
Secondary outcomes (7)
Changes from baseline in health-related quality of life (SF-12v2 health survey)
Measured: Baseline and 6 months
Changes from baseline in depressive symptoms (Centre for Epidemiological Studies Depression Scale)
Measured: Baseline and 6 months
Changes from baseline in symptoms of anxiety (Generalized Anxiety Disorder Screener-7 Scale)
Measured: Baseline and 6 months
Changes from baseline in costs of use of health services (Health and Social Services Utilization Inventory)
Measured: Baseline and 6 months
Changes from baseline in fasting blood glucose (mmol/L)
Measured: Baseline and 6 months
Changes from baseline in HbA1C (%)
Measured: Baseline and 6 months
Changes from baseline in number of hypoglycemic events per week (blood glucose <4.0 mmol/L)
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionDec 2015
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 Diabetes Mellitus, Type 2Studies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Care Guelph, Guelph Wellington Seniors Association
- Responsible party
- Sponsor
- Investigators
- Maureen Markle-Reid, PhD, RN, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880476
- Sponsor's protocol ID
- Labarge-13-377
- Status last verified
- Jul 2016
- First submitted
- 14 Jun 2013
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Markle-Reid M, Ploeg J, Fisher K, Reimer H, Kaasalainen S, Gafni A, Gruneir A, Kirkconnell R, Marzouk S, Akhtar-Danesh N, Thabane L, Rojas-Fernandez C, Upshur R. The Aging, Community and Health Research Unit-Community Partnership Program for older adults with type 2 diabetes and multiple chronic conditions: a feasibility study. Pilot Feasibility Stud. 2016 May 9;2:24. doi: 10.1186/s40814-016-0063-1. eCollection 2016.
PubMed 27965843
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability and Effects of an Interprofessional Community-Based Health Promotion Intervention on Self-Management in Older Adults With Type 2 Diabetes and Comorbid Chronic Conditions: A Pilot Study
- ClinicalTrials.gov ID
- NCT01880476
- Acronym / sponsor ID
- Labarge-13-377
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Comorbidity, Aged, Health Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Diabetes Care Guelph, Guelph Wellington Seniors Association
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Jun 2013 (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.
This study will examine the feasibility and acceptability of a 6-month interprofessional community-based health promotion program, and explore its effects on older adults' self-management of Type 2 Diabetes (T2DM). Recently enrolled clients of Diabetes Care Guelph (DCG), who are age 65+ and have at least two other chronic conditions, will be eligible to participate. Participants must be English speaking, community-dwelling, independent in activities of daily living, and mentally competent to give informed consent. The 6-month intervention will consist of: in-home visits by a Registered Nurse and Registered Dietitian from DCG; participation in a monthly Diabetes Wellness Day group program offered through the Guelph Wellington Seniors Association (GWSA) together with DCG; peer support from trained volunteers at the Diabetes Wellness Day group program; care coordination by the DCG Registered Nurse to help participants access necessary supports and services; and monthly team conferences between care providers at DCG and the GWSA to develop a client-centred plan of care. To evaluate the program, participants will complete interviewer-administered questionnaires before and after the intervention, and care providers and peer volunteers will take part in group interviews.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home visits and group program | Experimental | Other: Home visits and group program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65+
- Referred to Diabetes Care Guelph within the past 12 months
- At least two chronic conditions in addition to Type 2 Diabetes Mellitus
- English speaking
- Community-dwelling, in the city of Guelph
Key exclusion criteria (0 listed)
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 group programParticipants will receive up to three home visits by a Registered Nurse and two home visits by a Registered Dietitian over the 6-month intervention period. Participants will also be invited to attend a monthly Diabetes Wellness Day group program which will include diabetes education, interaction with peer volunteers, group exercise, and a meal. The Registered Nurse will coordinate care to help participants access necessary community supports and services and lead monthly interprofessional case conferences to develop a client-centred plan of care for each study participant. | Other | Home visits and group program |
Primary outcome
Changes from baseline in the Summary of Diabetes Self-Care Activities questionnaire
Time frame: baseline and 6 months
This questionnaire measures self-care activities including diet, exercise, blood glucose testing, foot care, and smoking.
7 secondary outcomes
Changes from baseline in health-related quality of life (SF-12v2 health survey)
Time frame: Baseline and 6 months
Changes from baseline in depressive symptoms (Centre for Epidemiological Studies Depression Scale)
Time frame: Baseline and 6 months
Changes from baseline in symptoms of anxiety (Generalized Anxiety Disorder Screener-7 Scale)
Time frame: Baseline and 6 months
Changes from baseline in costs of use of health services (Health and Social Services Utilization Inventory)
Time frame: Baseline and 6 months
Changes from baseline in fasting blood glucose (mmol/L)
Time frame: Baseline and 6 months
Changes from baseline in HbA1C (%)
Time frame: Baseline and 6 months
Changes from baseline in number of hypoglycemic events per week (blood glucose <4.0 mmol/L)
Time frame: Baseline and 6 months
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 11 Jul 2016.
- Derived from this study: PubMed 27965843Markle-Reid M, Ploeg J, Fisher K, Reimer H, Kaasalainen S, Gafni A, Gruneir A, Kirkconnell R, Marzouk S, Akhtar-Danesh N, Thabane L, Rojas-Fernandez C, Upshur R. The Aging, Community and Health Research Unit-Community Partnership Program for older adults with type 2 diabetes and multiple chronic conditions: a feasibility study. Pilot Feasibility Stud. 2016 May 9;2:24. doi: 10.1186/s40814-016-0063-1. eCollection 2016.
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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, RN principal investigator
McMaster University
1 site 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 group program in people with Diabetes Mellitus, Type 2, run by McMaster University 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 7 inclusion and 0 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 11 Jul 2016. 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?
Changes from baseline in the Summary of Diabetes Self-Care Activities questionnaire (time frame: baseline and 6 months). 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 NCT01880476, 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 11 Jul 2016.