Diabetes Mellitus Self Management Education, Hypertension Self-management, Self Management
Conditions
Keywords
Older adults, Remote patient monitoring, Telehealth, Interprofessional
Brief summary
This clinical trial trial design will be a pretest-posttest comparison group pilot study that evaluates the implementation of team-based telemedicine visits and remote patient monitoring.
Interventions
BEHAVIORALRemote patient monitoring
The usual interprofessional program activities are delivered via remote patient monitoring kits. The kit includes a tablet for virtual visits with the Mobile Health and Wellness Team and access to educational videos, as well as at-home monitoring devices for blood pressure, blood sugar if diabetic, pulse ox if COPD, and/or weight scale.
BEHAVIORALTelephone
The usual interprofessional program activities are delivered via telephone visits without any at-home monitoring devices.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant in the Mobile Health and Wellness Program * 18 years old or over * Reporting with hypertension, diabetes, congestive heart failure, or chronic obstructive pulmonary disease * English-speaking * Currently taking blood pressure and/or diabetes medications * Capable of engaging with the Health Recovery Solutions (HRS) Remote Patient Monitoring (RPM) device or participating in standard telephone-based care.
Exclusion criteria
* Prior diagnosis of Dementia; Alzheimer's disease, Lewy body, Parkinson's, or vascular dementia. * No access to an internet connection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Self-Efficacy for Managing Chronic Conditions | Baseline, 8 weeks and through the end of participation at 16 weeks | Change in self-efficacy in managing chronic conditions at 16 weeks, the tool will be the PROMIS Self-Efficacy for Managing Chronic Conditions - The PROMIS Self-Efficacy scoring system is designed to assess the confidence of individuals in managing their health and daily activities. It is based on a T-score metric, where a score of 10 points corresponds to one standard deviation (SD) from the mean. The PROMIS scoring system has a mean of 50 and a standard deviation (SD) of 10 in the US General Population. A score of 40 is one SD lower than the mean, while a score of 60 is one SD higher. This scoring system is used to evaluate the self-efficacy for managing chronic conditions and daily activities, providing a standardized way to measure and compare the effectiveness of interventions and treatments. |
| The Medical Outcomes Study (MOS) Measures of Patient Adherence | Baseline, 8 weeks and through the end of participation at 16 weeks | Improved adherence to medical recommendations at 16 weeks, the tool will be The Medical Outcomes Study (MOS) Measures of Patient Adherence is a 5-item scale to assess the adherence of patients with chronic conditions to medical recommendations. To score a Medical Outcomes Study (MOS) survey, you first need to recode the raw survey responses according to the specific scale's rules. Then, you average the recoded item scores to get a subscale score. For an overall index, you average the scores for all relevant items. Finally, you can transform these average scores to a 0-100 scale, where 100 represents the best possible score. |
| The REALM Health Literacy | Baseline, 8 weeks and through the end of participation at 16 weeks | Change in health literacy at 16 weeks, The REALM Health Literacy - Short Form is a 7-item assessment tool that is a validated rapid measure of health literacy. It is a 7-item word recognition test to screen a patient's health literacy quickly. The patient is asked to read the words aloud. Scores are interpreted into a reading grade level equivalent, takes about one minute and requires minimal training. |
| Change in mobile device proficiency at 16 weeks | Baseline, 8 weeks and through the end of participation at 16 weeks | The Mobile Device Proficiency (MDPQ-16) is a 16-item survey measuring participants' ability to operate a mobile device. First, assign a numerical value from 1 to 5 to each item, with one being "Never Tried" and five being "Very Easily". Next, calculate the average score for each of the eight subscales (Mobile Device Basics, Communication, Data and File Storage, Internet, Calendar, Entertainment, Privacy, and Troubleshooting/Software Management). Finally, add the eight subscale averages to obtain a total score ranging from 8 to 40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Baseline, 8 weeks and through the end of participation at 16 weeks | Change in blood pressure (SBP/DBP) over the course of the 16 weeks, particularly for baseline to post-study in the remote group. Blood pressure is measured in units of millimeters of mercury (mmHg). The readings are always given in pairs, with the upper (systolic) value first, followed by the lower (diastolic) value. |
| Change in weight | Baseline, 8 weeks and through the end of participation at 16 weeks | Change in weight over the course of the 16 weeks, particularly for baseline to post study in the remote group. |
| Change in blood oxygenation | Baseline, 8 weeks and through the end of participation at 16 weeks | Measured by a pulse oximeter over the course of the 16 weeks, particularly for baseline to post-study in the remote group. (No range outcome necessary- continuous value) |
| Change in blood glucose | Baseline, 8 weeks and through the end of participation at 16 weeks | Change in blood glucose over the course of the 16 weeks, particularly for baseline to post study in the remote group. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLana Sargent
Virginia Commonwealth University
Outcome results
None listed