A Theory-Based Patient Portal eLearning Program for Older Adults With Chronic Illnesses
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
The high prevalence of chronic illnesses is a serious public health problem in the United States, accounting for 70% of all deaths. Older adults are especially vulnerable; more than 70 million adults age ≥50 have at least one chronic illness (e.g., heart disease, diabetes). Management of chronic conditions requires long-term use of multiple medications and complex treatment plans, which can cause unintended consequences, such as increased risk of medication errors. Engaging patients in their care and health decision-making processes is vital for the provision of high quality care to people with chronic conditions. Until recently, however, patients were not given access to their own health records and had to call their providers' offices to communicate with them. In the past few years, the nation has made unprecedented efforts to transform health care using information technology (IT). Through secure patient portals (PPs), patients now can access their electronic health records (EHRs), directly send eMessages to their providers, and request medication renewals online. They can also involve their family caregivers in their care more efficiently. PPs are especially helpful for patients with chronic illnesses, as they offer tools to manage health conditions. With the Meaningful Use (MU) incentive payment program by the Centers for Medicare and Medicaid Services (CMS), healthcare organizations nationwide are implementing PPs and making them available to the public.
Prior findings demonstrated positive impacts of PPs on management of chronic conditions, adherence to treatment, and patient-provider communication. Currently, PP adoption rates vary depending on care organizations, but the overall nationwide adoption rate has been low (26.8%). A lack of PP use among older adults has been addressed as a particular concern. Based on 2014 national survey data, however, when only online users were considered, the proportion of PP use in older adults was similar to other age groups (≥18 yrs, 32.2%; 50-64, 34.1%; ≥65, 29.8%). In a 2015 SeniorNet34 member survey (N=553; mean age, 73.6 yrs), 60.6% (n=327) reported having at least one PP account. These findings indicate an excellent potential for using PPs for the care of older adults (AHRQ's priority population36). Many older adults, however, are not technologically savvy and need additional support. Currently, most older adults receive little or no PP training support from their providers. This is a critical gap in the nation's health IT initiative because without appropriate support, older adults will not be able to use this robust health tool, missing an important opportunity to improve their health-related outcomes.
In an effort to fill this gap, in our previous studies the investigators developed and tested the older adult friendly Theory-based PP eLearning Program (T-PeP) to provide older adults necessary support for using PPs. In the proposed feasibility study, the investigators will optimize and implement the program in a large older adult online community, conduct formative/process evaluation, and assess its preliminary impact on PP use and selected health-related outcomes. T-PeP was developed based on self-efficacy theory to improve older adults' use of PPs for managing their care and includes learning modules, discussion boards, and other resources. Considering variations in the types and usability of PPs used by patients nationwide, T-PeP was developed as a vendor-agnostic ("not tied to a specific vendor") program. The specific aims of the study are to:
Aim 1: Optimize and implement T-PeP in an older adult online community and conduct formative and process evaluations (e.g., usability problems, barriers and facilitators for PP use, and other practical issues).
Aim 2: Assess the preliminary impact of T-PeP on older adults' PP use and selected health-related outcomes using a two-arm randomized controlled trial (RCT). Older adult online users with chronic conditions (N=242, age ≥50) will be recruited from a large older adult online community (SeniorNet.org).
H1. The intervention group participants will demonstrate greater improvement than the control group at the end of T-PeP (3 weeks) and at 4 months in PP knowledge, self-efficacy for using PPs and making health decisions, perceived patient-provider communication, and PP use (enrollment, usage frequency).
H2. More participants in the intervention group than the control group will reconcile the medications they are taking with the medications listed in their PP at 4 months.
This study could directly impact quality of care provided to older adults and the success of a national health IT initiative by offering a critically missing component in the current PP implementation process-patient support for the health IT (PP) designed for patients. Findings from the study will also provide hospitals, vendors, and policymakers in-depth information on older adults' current PP usage patterns and other challenges in using various PPs at the national level, contributing to the improvement of PP technology and clinical practices. Once the feasibility of the study is demonstrated, the vendor-agnostic T-PeP could be used widely and incorporated into busy practices. The next R01 study will test its long-term effects on health behavior and clinical outcomes, as well as care cost, using more diverse samples, including practice settings and underserved populations.
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Fort Myers, Florida, United States, 33907
- SeniorNet
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being age ≥50
- having been diagnosed with at least one chronic disease* (e.g., heart disease, diabetes, cancer)
- having access to the Internet/e-mail
- being able to use the Internet/e-mail independently
- currently residing in the U.S.
- being able to read/write English.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Theory-based PP eLearning Program(T-PeP)
Theory-based PP eLearning Program (T-PeP) was developed based on self-efficacy theory42-44 to improve older adults' use of PPs for managing their care and includes learning modules, discussion boards, and other resources.
Considering variations in the types and usability of PPs used by patients nationwide, T-PeP was developed as a vendor-agnostic ("not tied to a specific vendor") program.
|
Theory-based PP eLearning Program (T-PeP) was developed based on self-efficacy theory42-44 to improve older adults' use of PPs for managing their care and includes learning modules, discussion boards, and other resources.
Considering variations in the types and usability of PPs used by patients nationwide, T-PeP was developed as a vendor-agnostic ("not tied to a specific vendor") program.
|
|
No Intervention: Control Group
No specific intervention will be provided to the control group participants
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PP knowledge
Time Frame: Change from baseline knowledge at 3 week and 4 months
|
An 8-item questionnaire developed by experts and tested in preliminary studies (α=.50).40,41
|
Change from baseline knowledge at 3 week and 4 months
|
|
Self-efficacy for using PPs
Time Frame: Change from baseline knowledge at 3 week and 4 months
|
a modified 4-item Self-Efficacy for Computer-Based PHR Scale100 (α=.97; criterion validity), which was successfully used in our preliminary studies.40,41
|
Change from baseline knowledge at 3 week and 4 months
|
|
Self-efficacy for health decision making
Time Frame: Change from baseline knowledge at 3 week and 4 months
|
Decision Self-Efficacy Scale, including 11 items on a 5-point Likert scale.
The scale assesses the person's ability to obtain information, ask questions, and make a choice.136-138
It was tested for older adults in an eHealth study (α=.83; criterion validity).139
|
Change from baseline knowledge at 3 week and 4 months
|
|
Patient-provider communication
Time Frame: Change from baseline knowledge at 3 week and 4 months
|
14 items of the Components of Primary Care Instrument140,141 that assesses the following 3 areas: interpersonal communication, physician's knowledge of the patient, coordination of care.
This tool has been tested in our prior study40 (α=.89; factor analysis141).
|
Change from baseline knowledge at 3 week and 4 months
|
|
PP use
Time Frame: Change from baseline knowledge at 3 week and 4 months
|
The number of newly activated account(s) and the frequency of PP usage per function; lab results, medications, and health summaries; and other functions as reported in the scheduled surveys.
|
Change from baseline knowledge at 3 week and 4 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication reconciliation
Time Frame: Change from baseline knowledge at 3 week and 4 months
|
The frequency of comparing all medications that participants are taking with all medications listed on their PP142 as reported in the scheduled surveys.
|
Change from baseline knowledge at 3 week and 4 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HP-00069040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Disease
-
NCT05630729CompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage I
-
NCT04336033RecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic Dialysis
-
NCT06058754RecruitingChronic Disease | Chronic Conditions, Multiple | Chronic Condition
-
NCT05775653CompletedChronic Conditions, Multiple | Chronic Condition
-
NCT05972031RecruitingChronic Conditions, Multiple | Chronic Condition
-
NCT05495230CompletedChronic Conditions, Multiple | Chronic Condition
-
NCT06388499CompletedChronic Conditions, Multiple
-
NCT06629675RecruitingChronic Obstructive Pulmonary Disease (COPD) | Chronic Obstructive Lung Disease | Chronic Obstructive Airway Disease
-
NCT04828837TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With Exacerbation
-
NCT04617431CompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1
Clinical Trials on Theory-based PP eLearning Program(T-PeP)
-
NCT05835583CompletedSchizophrenia | Medication Adherence | Medication Compliance
-
NCT06850012Not yet recruitingMmigrant Nurses' Adaptation and Perceived Stress | Transition Theory in Immigrant Nurses | Social Adaptation and Stress in Immigrant Nurses | Professional Self-Efficacy
-
NCT06210659Not yet recruiting
-
NCT07607171CompletedMenstruation | Health Education | Visually Impaired Persons | Nursing | Self-care | Menstruation Hygiene
-
NCT07326787CompletedSocial Cognitive Theory-Based Educational Intervention Program on Sustainable Eco-Friendly NutritionSelf Efficacy | Adolescent Nutrition | Sustainable Eco-Friendly Nutrition
-
NCT06453811CompletedFear of Childbirth | Mode of Delivery | Childbirth Self-Efficacy | Childbirth Preparation Program
-
NCT02328638Completed
-
NCT03400891CompletedChildhood Obesity | Healthy Diet | Eating Behavior | Fruit and Vegetable Intake
-
NCT03899831CompletedAutism Spectrum Disorder
-
NCT07454538CompletedSafety | Education, Nursing | Self Administration | Education Entertainment Intervention | Preschool Age Children