Multiple Chronic Conditions
Conditions
Keywords
multiple chronic conditions, mobile health, multimorbidity
Brief summary
The purpose of this pilot study is to evaluate the feasibility and impact of delivering mobile health self-management interventions to improve adherence to the prescribed treatment in a multimorbid population returning home after hospital discharge.
Detailed description
The purpose of this three-group repeated-measures randomized controlled trial is to evaluate the use of mobile health (mHealth) self-management technology as a model of care for individuals with multimorbidity. Specifically, this 8-week self-management intervention uses tailored self-management strategies (action planning, goal setting, and individually identified support needs) and mHealth technology for real-time virtual visits, daily messages, and self-monitoring activities. The investigators are testing the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the mHealth platform (mHealth Plus). The NP evaluates physiological status by evaluating symptoms and tailoring the intervention specific to the individual's multimorbidity while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers. The following specific aims will be addressed: Aim 1: To evaluate the feasibility of implementing comparative SM interventions (mHealth and mHealth plus virtual visits with a nurse practitioner and community health worker team) in multimorbid individuals by assessing: a) acceptability of each intervention; b) enrollment (recruitment efficiency, attrition, problems and solutions); c) intervention fidelity (delivery, receipt, enactment of the intervention \[benefits and barriers\]); and d) data collection (technological transfer of data, instrument reliability, the time required, missing data). Aim 2: To examine the impact of delivering the m-Health and m-Health plus interventions compared to standard care (SC) in multimorbid individuals on: a) primary outcome: adherence to disease-specific lifestyle behaviors (e.g. diet and medication, and self-monitoring of physiological measures as needed (e.g. weight blood pressure, blood glucose, oxygen saturation); b) secondary outcomes: health related quality of life; c) patient-reported health status; d) symptom status; and e) healthcare utilization.
Interventions
BEHAVIORALmHealth intervention
The intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses mobile health (m-Health) technology for daily messages and reminders to promote self-monitoring activities. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine).
BEHAVIORALmHealth Plus
The intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses tailored self-management strategies (action planning, goal setting, and individual identified support needs) and mobile health (m-Health) technology for virtual visits, daily messages, and self-monitoring activities. The investigators will test the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the m-health platform. The NP will evaluate physiological and psychosocial status while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine). Participants will receive reminders through the platform.
Sponsors
Greater Plains Collaborative Clinical Data Research Network
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
No masking
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. multimorbid patients with one of 4 chronic conditions (HF, COPD, diabetes or hypertension) and have at least one other chronic disease (i.e., hypertension, cancer, stroke, heart disease, diabetes, arthritis, hepatitis, current asthma, kidney failure, or COPD), 2. adult patients (age 19 and older) 3. access to smart technology (phone or iPad) and internet access or a phone plan large enough for daily interactions; and d) able to hear, speak and read English.
Exclusion criteria
1. major surgery while admitted; 2. discharged to somewhere other than home (e.g., long term care facility); 3. receiving home health services; 4. documented dementia; and 5. life expectancy \<6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability and acceptability of the self-management interventions by administering a Usability and Acceptability tool | 60 days after enrolled | A Usability and Acceptability investigator developed tool. |
| Enrollment of participants to the comparative self-management (SM) interventions by calculating frequency and percentage of available participants and enrolled participants. | 90 days after enrolled | measure of enrollment and recruitment |
| Number of times the participant records activities within the application. | 90 days after enrollment | Measurement of engagement with the application, participant records will be downloaded from the application and frequency and percent will be calculated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and percent of the participants recording a blood glucose in the mHealth app | 30 days after intervention initiated | monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of blood glucose readings recorded for the diabetic participant) |
| Health related quality of life assessed by the EQ-5D-5L developed by the EuroQol group scored as an index and a visual analogue scale. | 30 days after intervention initiated | monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of blood glucose readings recorded for the diabetic participant) |
| Frequency and percent of the participants recording a weight in pounds in the mHealth app | 30 days after intervention initiated | monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of weights recorded for heart failure participant) |
| Patient Reported Outcomes Measurement Information System PROMIS® (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today | 60 days after intervention initiated | measure of health status and symptoms |
| Emergency rooms visits and re-hospitalizations assessed by frequency and percent assessed by reviewing the electronic medical record | 30 days after intervention initiated | measure of health care utilization |
| Patient Reported Outcomes Measurement Information System (PROMIS®) (Promis29 V2.0) score of mobility, self-care, usual activities, pain/ discomfort, anxiety/ depression and a visual analogue scale rating of health today | 30 days after intervention initiated | Measure of health status and symptoms |
| Frequency and percent of the participants recording a blood pressure (BP) in the mHealth app | 30 days after intervention initiated | monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease (number of BP recorded for hypertension participant) |
| Frequency and percent of the participants recording a pulse oximetry in the mHealth app | 30 days after intervention initiated | monitoring of physiological measures for each of the physiologic parameters appropriate for the participants chronic disease. (number of oximetry readings recorded for chronic obstructive pulmonary disease (COPD) participant) |
Countries
United States
Outcome results
None listed