Congestive Heart FailureNCT00147706
Does Access to an EHR Patient Portal Influence Chronic Disease Outcomes?
A study testing Tailored Healthmedia programs on EHR Patient Portal in people with Congestive Heart Failure and Diabetes, run by Robert Wood Johnson Foundation at 1 site in United States.
Trial summary
The purpose of this study is to determine if patients with congestive heart failure, diabetes or secondary cardiovascular diseases, who access HealthMedia's online tailored behavior change programs on the electronic health record patient portal have better clinical and behavioral change outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Diabetes, Cardiovascular Disease
- What is being tested?
- Tailored Healthmedia programs on EHR Patient Portal
- Type of treatment
- Surgery or procedure
- How many people
- 6,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2006
- 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
- Adult age 18 years or older
- Have medical records in the Geisinger Electronic Health Record
- Have congestive heart failure and/or Diabetes and/or cardiovascular disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Health Research & Rural Advocacy. Geisinger Clinic
Danville, Pennsylvania, 17822-2602
About this study
Official title: Does Access to an EHR Patient Portal Influence Chronic Disease Outcomes? A Randomised Trial Assessing Clinical and Behavioural Change Outcomes in Patients With CHF, Diabetes, or Secondary CVD
The purpose of this study is to determine if patients with congestive heart failure, diabetes or secondary cardiovascular diseases, who access HealthMedia's online tailored behavior change programs on the electronic health record patient portal have better clinical and behavioral change outcomes.
Read the detailed description
The specific aims of the study are to determine if e-portal interventions influence:
- Measures of patient activation, patient self-management, treatment adherence, patient satisfaction with care, and disease specific knowledge.
- Process measures relevant to appropriate care for CVD, CHF, and DM.
- Clinical markers of cardiovascular or diabetes morbidity and risk.
These aims will be evaluated in one-year prospective study. Patients who use the portal will be randomized to control (i.e., access to routine portal-related information) and intervention groups (i.e., targeted and periodic messages designed to capture data relevant to self-management; to improve knowledge of their specific disease, tests, and risks; to devise time-dependent goals; and to motivate self-efficacy). Outcomes including activation, satisfaction, and adherence will be measured by telephone interview prior to and one year after intervention, and by lab and clinical measures and data available from the EHR. We will also evaluate potential selection issues among those who sign on to the e-portal by administering the same baseline interview to a matched (by disease and by age) random sample of patients who do not sign on to the e-portal.
Patients with chronic diseases are likely to experience particular benefit from online e-health resources as they have greater information needs and participate in self-management.(Camer, 2000) Unlike traditional office visits, online interactions eliminate the need to travel, are always available and give the patient access to a broad range of information, helping them actively participate in their own care.(Brown, 1999) There is growing evidence that patient education and engagement using e-health applications results in improved patient outcomes in the care of chronic illnesses, improved patient-physician communication, and reduction of anxiety for caregivers.(Brennan et al., 2001; Bronson et al., 1986; Bronson \& O'Meara, 1986; Ross et al., 2003a, 2003b) We anticipate demonstrating clinically meaningful improvements in chronic disease health status, using evidence-based science delivered in behaviorally-validated ways.
- Conditions
- Congestive Heart Failure, Diabetes, Cardiovascular Disease
- Being tested
- Tailored Healthmedia programs on EHR Patient Portal
- Keywords
- Electronic Health Record, Patient Portal, Chronic Diseases
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Cardiovascular Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Healthmedia programs on EHR Patient PortalProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge, behavior change, relevant clinical measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health
- Investigators
- Walter F Stewart, PhD, Principal investigator, Geisinger Health SystemsNirav R Shah, MD. MPH, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147706
- Sponsor's protocol ID
- 051761
- Status last verified
- Jul 2011
- First submitted
- 2 Sep 2005
- Last updated
- 26 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Access to an EHR Patient Portal Influence Chronic Disease Outcomes? A Randomised Trial Assessing Clinical and Behavioural Change Outcomes in Patients With CHF, Diabetes, or Secondary CVD
- ClinicalTrials.gov ID
- NCT00147706
- Acronym / sponsor ID
- 051761
- Conditions
- Congestive Heart Failure, Diabetes, Cardiovascular Disease
- Keywords
- Electronic Health Record, Patient Portal, Chronic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Collaborators
- NYU Langone Health
- Study start
- Sep 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 7 Sep 2005 (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 purpose of this study is to determine if patients with congestive heart failure, diabetes or secondary cardiovascular diseases, who access HealthMedia's online tailored behavior change programs on the electronic health record patient portal have better clinical and behavioral change outcomes.
Detailed description
The specific aims of the study are to determine if e-portal interventions influence:
- Measures of patient activation, patient self-management, treatment adherence, patient satisfaction with care, and disease specific knowledge.
- Process measures relevant to appropriate care for CVD, CHF, and DM.
- Clinical markers of cardiovascular or diabetes morbidity and risk.
These aims will be evaluated in one-year prospective study. Patients who use the portal will be randomized to control (i.e., access to routine portal-related information) and intervention groups (i.e., targeted and periodic messages designed to capture data relevant to self-management; to improve knowledge of their specific disease, tests, and risks; to devise time-dependent goals; and to motivate self-efficacy). Outcomes including activation, satisfaction, and adherence will be measured by telephone interview prior to and one year after intervention, and by lab and clinical measures and data available from the EHR. We will also evaluate potential selection issues among those who sign on to the e-portal by administering the same baseline interview to a matched (by disease and by age) random sample of patients who do not sign on to the e-portal.
Patients with chronic diseases are likely to experience particular benefit from online e-health resources as they have greater information needs and participate in self-management.(Camer, 2000) Unlike traditional office visits, online interactions eliminate the need to travel, are always available and give the patient access to a broad range of information, helping them actively participate in their own care.(Brown, 1999) There is growing evidence that patient education and engagement using e-health applications results in improved patient outcomes in the care of chronic illnesses, improved patient-physician communication, and reduction of anxiety for caregivers.(Brennan et al., 2001; Bronson et al., 1986; Bronson \& O'Meara, 1986; Ross et al., 2003a, 2003b) We anticipate demonstrating clinically meaningful improvements in chronic disease health status, using evidence-based science delivered in behaviorally-validated ways.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult age 18 years or older
- Have medical records in the Geisinger Electronic Health Record
- Have congestive heart failure and/or Diabetes and/or cardiovascular disease
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 |
|---|---|---|
| Tailored Healthmedia programs on EHR Patient Portal | Procedure or surgery | – |
Primary outcome
knowledge, behavior change, relevant clinical measures
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 26 Jul 2011.
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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.
Walter F Stewart, PhD principal investigator
Geisinger Health Systems
Nirav R Shah, MD. MPH study chair
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Healthmedia programs on EHR Patient Portal in people with Congestive Heart Failure and Diabetes, run by Robert Wood Johnson Foundation at 1 site in United States.
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 3 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 26 Jul 2011. 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 United States. 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?
knowledge, behavior change, relevant clinical measures. 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 26 Jul 2011.