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Type 2 Diabetes MellitusTAP-HC-DMNCT02715791

TAPESTRY With Health Connnectors for Diabetes Management

A study testing TAP-HC-DM in people with Type 2 Diabetes Mellitus and Hypertension, run by McMaster University at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The TAPESTRY-HC-DM approach is designed to support self-management of chronic disease by strengthening connections between patients and the primary healthcare system through "health connectors" -both volunteers and technology including the TAPESTRY Healthy Lifestyle App and McMaster Personal Health Record (PHR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus, Hypertension
What is being tested?
TAP-HC-DM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesCanada
Study dates
Feb 2016to 26 Sep 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Active patient at McMaster Family Health Team
  • Aged 18+
  • Diagnosis of Diabetes
  • Diagnosis of Hypertension
  • Regular access to a computer
  • And at least ONE of:
Show all 11Show fewer
  • Uncontrolled HbA1C measures (in the past 6 months, or most recent) - 10
  • Uncontrolled recent blood pressure (in the past 3 months, or most recent) - 140/90 or higher (either number higher)
  • Newly diagnosed with diabetes (diagnosed within 6 months)
  • End-stage organ damage/other complications of diabetes [e.g. renal dysfunction, diabetic neuropathy]
  • Doctor Recommendation

Who cannot join

  • identified as deceased
  • explicitly stated they do not want to be part of a research project
  • reside in long-term care
  • are receiving end-of-life care
  • directly related to anyone from the McMaster University Department of Family Medicine
  • not a participant in another TAPESTRY project

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • McMaster Family Health Practice

    Hamilton, Ontario, L8P 1H6

  • McMaster University Department of Family Medicine

    Hamilton, Ontario, L8P 1H6

  • Stonechurch Family Health Centre

    Hamilton, Ontario, L8W 3J6

Other trials in Canada

About this study

Official title: Teams Advancing Patient Experience: Strengthening Quality for People Through Health Connectors for Diabetes Management (TAPESTRY-HC-DM): A Feasibility RCT

The TAPESTRY-HC-DM approach is designed to support self-management of chronic disease by strengthening connections between patients and the primary healthcare system through "health connectors" -both volunteers and technology including the TAPESTRY Healthy Lifestyle App and McMaster Personal Health Record (PHR). It will explore whether strengthening primary care connections across patients, providers, and community organizations through TAPESTRY-HC-DM - i.e., the deployment of volunteer health connectors coordinated by a community organization, the use of the TAPESTRY Healthy Lifestyle e-Application by patients, and care coordination processes by the interprofessional primary healthcare team - can increase self-efficacy in managing chronic conditions.

Read the detailed description

TAP-HC-DM is a feasibility randomized controlled trial (RCT) involving various pieces of intervention and their interactions to form a complex adaptive system. The purpose of the trial is to assess the effectiveness of the intervention not only through evaluating patient outcomes, but also through understanding the process of implementation and its fidelity to core elements.

The trial will be conducted within the McMaster Family Health Team (MFHT) in Hamilton, Ontario. The MFHT consists of two sites, with approximately 30,000 patients, as well as 30 family physicians, 70 family medicine residents, 10 nurse practitioners and other healthcare professionals.

Initial lists of potential participants will be created using an algorithm based on the inclusion criteria that will be run on the clinics' electronic medical records systems, with manual chart audits completed afterwards on an as-needed basis. The family physicians will then be asked to vet this list for further exclusion criteria. Patients from the list will then be sent a package including an invite letter from their family physician and a consent form.

Participants who have consented, will receive a welcome call from volunteers who will then provide detailed description of the program and expectations. The clients will then be invited to sign up for McMaster Personal Health Record (PHR) and asked to complete the modules (Diabetes, Hypertension, Sleep, Exercise, Nutrition, Medications, PHR) on the Healthy Lifestyle app. After completion of the modules, participants will receive a report and suggested tip sheets based on their responses. Volunteers as health connectors will connect with clients weekly, providing motivation, education, tech support, and community connections. The healthcare teams at the clinics will also receive the report and will triage it in their weekly huddles. Any follow-up recommended by the clinics will be communicated to volunteers who will then work with clients on the given recommendations, or directly to patients.

Being tested
TAP-HC-DM, Usual Care
Keywords
Self-Management, Health Connectors, Volunteers, Technology, Interprofessional team, Chronic disease, Self-efficacy, Patient-centredness, Community Engagement
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAP-HC-DMBehavioural

    Patients randomized to the intervention group will complete the Healthy Lifestyle App modules. Their results will create a report with a suggested list of tip sheets that patients, volunteers, and clinics will see.

    Patients will also be encouraged to access the McMaster PHR in order to track their health, and communicate with volunteers or the clinic.

    Volunteer health connectors will connect with patients at least weekly, by phone, McMaster PHR message, or in person (depending on patient preference). They will be motivating, providing tip sheets or other education, doing tech support, providing community resources, and building a volunteer-patient relationship with the client.

    Clinicians will see and triage the reports, and may follow up on various aspects identified.

  • Usual CareOther

    Patients randomized to the control group will receive usual care and upon the end of the intervention arm of the study will receive the TAPESTRY-HC-DM intervention as detailed in the intervention group.

Study groups in NCT02715791
Study groupRoleWhat they receive
Usual CareOtherPatients randomized to the control group will receive usual care and upon the end of study will receive access to the Healthy Lifestyle App and the McMaster PHR
Receives: Other: Usual Care
TAP-HC-DMOtherPatients randomized to the intervention group will get TAP-HC-DM intervention from time zero
Receives: Behavioral: TAP-HC-DM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diabetes self-efficacy

    This is the primary outcome which will be measured by Stanford Diabetes Self-Efficacy Scale, an 8-item scale.

    Measured: 4-month

Secondary outcomes (9)

  1. Self-efficacy in Managing General Chronic Conditions

    The outcome will be measured by a 6-item Stanford Self-Efficacy Scale for Managing Chronic Disease. It covers several domains that are common across many chronic diseases, symptom control, role function, emotional functioning and communicating with physicians.

    Measured: 4-month

  2. Attainment of Health Goals

    The outcome will be assessed using a Goal Attainment Scale (GAS) Questionnaire

    Measured: 4-month

  3. Assessment of Care for Chronic Conditions

    The outcome will be assessed using Assessment of Care for Chronic Conditions survey having 20 items

    Measured: 4-month

  4. Patient Empowerment

    The outcome will be assessed using Patient Empowerment questionnaire, a 5-item survey questionnaire and Canadian Institutes of Health Research (CIHR) Common Indicator for the Community- Based Primary Health Care (CBPHC)

    Measured: 4-month

  5. Patient Centredness

    The outcome will be assessed using Patient Centeredness questionnaire, a 6-item questionnaire and CIHR Common Indicator for the Community- Based Primary Health Care (CBPHC)

    Measured: 4-month

  6. Satisfaction with Healthcare

    This will be measured using a one item questionnaire that inquires how clients would like to rate the quality of healthcare they received on a scale of 0-100 (0=not satisfied, 100=completely satisfied)

    Measured: 4-month

  7. Patient Activation

    This will be assessed by a 13-item Patient Activation Measure (PAM) questionnaire.

    Measured: 4-month

  8. Patient Readiness for Change

    Readiness-for-Change Questionnaire (RCQ) for Diabetes Self-Management will be used to examine the clients' stage of readiness for diabetes management behaviour change (pre-contemplation, contemplation, action, maintenance), developed based on the Cardiovascular Risk Reduction Program Readiness-to-Change Lifestyle Behavior

    Measured: 4-month

  9. Physical Activity

    This will be assessed using the Rapid Assessment of Physical Activity (RAPA).

    Measured: 4-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2016
  4. Study completion26 Sep 2017

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715791
Sponsor's protocol ID
0744
Acronym
TAP-HC-DM
Status last verified
Oct 2017
First submitted
3 Nov 2015
Last updated
4 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Agarwal G, Gaber J, Richardson J, Mangin D, Ploeg J, Valaitis R, Reid GJ, Lamarche L, Parascandalo F, Javadi D, O'Reilly D, Dolovich L. Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams. Pilot Feasibility Stud. 2019 Oct 27;5:118. doi: 10.1186/s40814-019-0504-8. eCollection 2019.

    PubMed 31673398

Questions about this trial

What is this clinical trial studying?

A study testing TAP-HC-DM in people with Type 2 Diabetes Mellitus and Hypertension, run by McMaster University at 3 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 11 inclusion and 6 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 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Diabetes self-efficacy (time frame: 4-month). 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 NCT02715791, 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 4 Oct 2017.

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