Diabetes Mellitus, Type 2REACHNCT02757937
Reaching Better Health Study: A Website to Improve Type 2 Diabetes Self-Management
A study testing Health & Wellness Website in people with Diabetes Mellitus, Type 2, run by Children's Hospital of Philadelphia.
Trial summary
Diabetes is one of the most common chronic illnesses among adults in the United States. Internet-based interventions and health promotion websites for patients with Type 2 Diabetes are typically low-cost, easily accessible, and attractive. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Health & Wellness Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 513 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 31 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a current patient in the Penn Medicine outpatient healthcare system
- Patient's Primary Care Physician (PCP) or Endocrinologist is a Penn Medicine provider
- Patient has a 12 month history of healthcare utilization in the Penn Medicine system (in-office PCP/endocrinologist visits)
- Patient has complete data (ICD-10 code for Type 2 diabetes diagnosis, date of diagnosis, name and mailing address information) in the Penn Data Warehouse
- Patient is diagnosed with Type II Diabetes as indicated by ICD-10 Codes: E11.** (including any newly diagnosed)
- Patients' HbA1c was ≥8.0% in last 6 months (if more than one A1c result present in record, most recent measurement assessed)
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- Patient can read and understand English well enough to complete study tasks.
- Patient has regular access to a telephone
- Patient has at least bi-weekly access to internet and email
- Patient agrees to release their medical record information to Children's Hospital of Philadelphia research team
Who cannot join
- Patient is deceased
- Patient has indicated "Do Not Solicit for Research" in medical record
- Patient is less than 18 years of age
- Patient is older than 75 years old
- Patient uses an insulin pump or injectable insulin to treat/manage their diabetes.
- Patient is non-English speaking
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- Patient does not have HbA1c% in chart from last 6 months
- Patients' HbA1c in last 6 months is <8.0%
- Patient is currently taking medications that can raise glucose levels, such as steroids
- Patient has a history of cognitive disorders, mental illness, and/or cognitive impairment that may impact their ability to use an online website, including, dementia, Alzheimer's disease, Parkinson's disease, traumatic brain or head injury, and psychosis
- Patient has history of Heart Failure (included Chronic Heart Disease, Chronic Heart Failure) and/or Chronic Kidney Disease, and has had other serious cardiovascular conditions (e.g, heart attack or stroke) in the last 6 months
- Patient has history of endocrine gland cancers or pancreatic cancers
- Patient is undergoing chemotherapy or immunotherapy treatment in last 6 months
- Patient's medical record contains ICD-10 Code for Type I diabetes diagnosis.
- Patient's medical record contains ICD-10 Code for pregnancy-related diabetes:
- 024.419 (gestational diabetes)
- 024.419 (antepartum gestational diabetes)
- Z79.4 (type II long term insulin use)
- 024.91x (pregnant women who are diabetic)
- Patient is Pre-diabetic or borderline Type 2 diabetic
- Patient is pregnant or lactating
- Patient's electronic medical history data is not available through Penn Medicine's electronic medical record and/or is not complete in Penn Data Store
- Patients who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
About this study
Official title: Study to Measure Merck Engage Usability and Conduct Outcomes Testing
Diabetes is one of the most common chronic illnesses among adults in the United States. Internet-based interventions and health promotion websites for patients with Type 2 Diabetes are typically low-cost, easily accessible, and attractive. The purpose of this study is to determine whether participants' utilization of a health \& wellness website focused on diabetes self-management increases participants' self-reported self-efficacy toward managing their Type 2 Diabetes through behavior change and self-reported medication adherence compared to standard care.
Read the detailed description
Diabetes is one of the most common chronic illnesses among adults in the United States. Merck \& Co., Inc. has produced an innovative website to engage adult patients in chronic illness self-management and medication adherence. Internet-based interventions and health promotion websites for patients are typically low-cost, easily accessible, and attractive. However, there is a growing need for improved measurement, implementation and evaluation of online health interventions to ensure patient engagement and produce more significant behavior change that can impact patients' health over the long term.
The primary objective of this study is to determine whether utilization of the health and wellness website increases participants' self-reported self-efficacy toward managing their Type 2 Diabetes through behavior change and self-reported medication adherence.
This study comprises a randomized controlled trial utilizing the website as the self-management support intervention. There is no interventional medical treatment, and no change in patients' medical care. In collaboration with University of Pennsylvania, potential participants will be identified and recruited from the Penn Medicine outpatient population based on specific inclusion/exclusion criteria. Participants will remain in the study for 6 months.
Participants will be randomly assigned to the intervention or control condition (no exposure). Those in the intervention arm will have access to health \& wellness website for nine months post enrollment. Online surveys will be delivered during this nine month period. Primary outcomes will be baseline-to-two month and baseline-to-4 month changes in diabetes management self-efficacy scores as measured by the Diabetes Self-Efficacy Scale.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Health & Wellness Website, Control Arm
- Keywords
- Medication Adherence, Self-efficacy, Behavior, Diabetes, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence, Behavior, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health & Wellness WebsiteBehavioural
Educational website for patients with chronic disease (i.e., Type 2 diabetes, asthma, high blood pressure, high cholesterol). The website is a free interactive resource to help patients manage their health condition(s) each day and to help them achieve their goals. It is a multichannel health and wellness platform to help patients adhere to their treatment and care plans between office visits.
Control ArmOther
Continue with standard diabetes care without getting access to the intervention website.
| Study group | Role | What they receive |
|---|---|---|
| Health & Wellness Website | Experimental | Subjects will receive access to an interactive health \& wellness website for 6 months. The site aims to provide patients with information, tools, and resources to manage their chronic condition (e.g., Type 2 diabetes). The website will send subjects emails with tips to help them take better care of their diabetes, such as how to track diet and exercise habits and how to cook healthy meals. The study researchers will keep track of how many times subjects access the website and which parts of the site are most commonly viewed. Intervention subjects will receive questionnaires assessing engagement and satisfaction with the website. Subjects will also complete questionnaires at baseline and 2, 4, and 6 months post-baseline. Receives: Behavioral: Health & Wellness Website |
| Control Arm | Other | Subjects in the control arm will continue with standard diabetes care without getting access to the intervention website. Subjects will also complete questionnaires at baseline and 2, 4, and 6 months post-baseline. Control subjects will be granted access to the health \& wellness website after the study is completed. Receives: Other: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diabetes Self-Efficacy Scale Score from Baseline to 4 Months
The validated Diabetes Self-Efficacy Scale (Lorig et al., 2009) assesses how confident one is in doing certain activities related to diabetes management. There are 8 items in this measure with each one pertaining to a different activity. Each item is rated on a continuous scale of 1 to 10, 1 being not at all confident and 10 being totally confident. The score for each item is the number circled and higher value score indicates greater self-efficacy.
Measured: Baseline to 4 months
Secondary outcomes (3)
Change in Diabetes Knowledge Test Score from Baseline to 4 Months
This is a 14 item assessment, measuring general diabetes knowledge, was validated among Type 1 and Type 2 adult diabetics, Cronbach's α = 0.71. Each item is a multiple choice question, with options A-D. For scoring, the total number of questions answered correctly is calculated. The higher the score on the test, the greater knowledge one has about diabetes.
Measured: Baseline to 4 months
Change in Self-Efficacy Scale Score for Managing Chronic Disease from Baseline to 4 Months
This measure assesses how confident one is when performing various activities related to chronic disease management. There are 6 items on this scale with each one pertaining to a different activity. Each item is rated on a continuous scale of 1 to 10, with 1 being not at all confident and 10 being totally confident. The overall score for the measure is the average value of all the items. A higher score indicates a greater self-efficacy.
Measured: Baseline to 4 Months
Change in glycated haemoglobin (HbA1c) from Baseline to 6 Months
By measuring glycated haemoglobin (HbA1c), clinicians are able to get an overall picture of what average blood sugar levels have been over a period of weeks/months. For people with diabetes this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications.
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMay 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Linda Fleisher, PhD, MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757937
- Sponsor's protocol ID
- 15-011892
- Acronym
- REACH
- Status last verified
- Dec 2018
- First submitted
- 25 Apr 2016
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Measure Merck Engage Usability and Conduct Outcomes Testing
- ClinicalTrials.gov ID
- NCT02757937
- Acronym / sponsor ID
- REACH / 15-011892
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Medication Adherence, Self-efficacy, Behavior, Diabetes, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University of Pennsylvania
- Study start
- May 2016
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 2 May 2016 (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.
Diabetes is one of the most common chronic illnesses among adults in the United States. Internet-based interventions and health promotion websites for patients with Type 2 Diabetes are typically low-cost, easily accessible, and attractive. The purpose of this study is to determine whether participants' utilization of a health \& wellness website focused on diabetes self-management increases participants' self-reported self-efficacy toward managing their Type 2 Diabetes through behavior change and self-reported medication adherence compared to standard care.
Detailed description
Diabetes is one of the most common chronic illnesses among adults in the United States. Merck \& Co., Inc. has produced an innovative website to engage adult patients in chronic illness self-management and medication adherence. Internet-based interventions and health promotion websites for patients are typically low-cost, easily accessible, and attractive. However, there is a growing need for improved measurement, implementation and evaluation of online health interventions to ensure patient engagement and produce more significant behavior change that can impact patients' health over the long term.
The primary objective of this study is to determine whether utilization of the health and wellness website increases participants' self-reported self-efficacy toward managing their Type 2 Diabetes through behavior change and self-reported medication adherence.
This study comprises a randomized controlled trial utilizing the website as the self-management support intervention. There is no interventional medical treatment, and no change in patients' medical care. In collaboration with University of Pennsylvania, potential participants will be identified and recruited from the Penn Medicine outpatient population based on specific inclusion/exclusion criteria. Participants will remain in the study for 6 months.
Participants will be randomly assigned to the intervention or control condition (no exposure). Those in the intervention arm will have access to health \& wellness website for nine months post enrollment. Online surveys will be delivered during this nine month period. Primary outcomes will be baseline-to-two month and baseline-to-4 month changes in diabetes management self-efficacy scores as measured by the Diabetes Self-Efficacy Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health & Wellness Website | Experimental | Behavioral: Health & Wellness WebsiteSubjects will receive access to an interactive health \& wellness website for 6 months. The site aims to provide patients with information, tools, and resources to manage their chronic condition (e.g., Type 2 diabetes). The website will send subjects emails with tips to help them take better care of their diabetes, such as how to track diet and exercise habits and how to cook healthy meals. The study researchers will keep track of how many times subjects access the website and which parts of the site are most commonly viewed. Intervention subjects will receive questionnaires assessing engagement and satisfaction with the website. Subjects will also complete questionnaires at baseline and 2, 4, and 6 months post-baseline. |
| Control Arm | Other | Other: Control ArmSubjects in the control arm will continue with standard diabetes care without getting access to the intervention website. Subjects will also complete questionnaires at baseline and 2, 4, and 6 months post-baseline. Control subjects will be granted access to the health \& wellness website after the study is completed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is a current patient in the Penn Medicine outpatient healthcare system
- Patient's Primary Care Physician (PCP) or Endocrinologist is a Penn Medicine provider
- Patient has a 12 month history of healthcare utilization in the Penn Medicine system (in-office PCP/endocrinologist visits)
- Patient has complete data (ICD-10 code for Type 2 diabetes diagnosis, date of diagnosis, name and mailing address information) in the Penn Data Warehouse
- Patient is diagnosed with Type II Diabetes as indicated by ICD-10 Codes: E11.** (including any newly diagnosed)
Key exclusion criteria (23 listed)
- Patient is deceased
- Patient has indicated "Do Not Solicit for Research" in medical record
- Patient is less than 18 years of age
- Patient is older than 75 years old
- Patient uses an insulin pump or injectable insulin to treat/manage their diabetes.
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 |
|---|---|---|
| Health & Wellness WebsiteEducational website for patients with chronic disease (i.e., Type 2 diabetes, asthma, high blood pressure, high cholesterol). The website is a free interactive resource to help patients manage their health condition(s) each day and to help them achieve their goals. It is a multichannel health and wellness platform to help patients adhere to their treatment and care plans between office visits. | Behavioural | Health & Wellness Website |
| Control ArmContinue with standard diabetes care without getting access to the intervention website. | Other | Control Arm |
Primary outcome
Change in Diabetes Self-Efficacy Scale Score from Baseline to 4 Months
Time frame: Baseline to 4 months
The validated Diabetes Self-Efficacy Scale (Lorig et al., 2009) assesses how confident one is in doing certain activities related to diabetes management. There are 8 items in this measure with each one pertaining to a different activity. Each item is rated on a continuous scale of 1 to 10, 1 being not at all confident and 10 being totally confident. The score for each item is the number circled and higher value score indicates greater self-efficacy.
3 secondary outcomes
Change in Diabetes Knowledge Test Score from Baseline to 4 Months
Time frame: Baseline to 4 months
Change in Self-Efficacy Scale Score for Managing Chronic Disease from Baseline to 4 Months
Time frame: Baseline to 4 Months
Change in glycated haemoglobin (HbA1c) from Baseline to 6 Months
Time frame: Baseline to 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 17 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Linda Fleisher, PhD, MPH principal investigator
Children's Hospital of Philadelphia
Questions about this trial
What is this clinical trial studying?
A study testing Health & Wellness Website in people with Diabetes Mellitus, Type 2, run by Children's Hospital of Philadelphia.
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 10 inclusion and 23 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 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Diabetes Self-Efficacy Scale Score from Baseline to 4 Months (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2018.