University of Nebraska Medical Center, College of Nursing
Lincoln, Nebraska, 68588, United States
NCT Number: NCT04566107
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Lincoln, Nebraska, 68588, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: 60 days after enrolled
A Usability and Acceptability investigator developed tool.
Time frame: 90 days after enrolled
measure of enrollment and recruitment
Time frame: 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
Time frame: 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)
Time frame: 60 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)
Time frame: 90 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)
Time frame: 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)
Time frame: 60 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)
Time frame: 90 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)
Time frame: 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)
Time frame: 60 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 (COPD) participant)
Time frame: 90 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 the chronic obstructive pulmonary disease (COPD) participant)
Time frame: 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)
Time frame: 60 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)
Time frame: 90 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)
Time frame: 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)
Time frame: 60 days after intervention initiated
Measure of quality of life
Time frame: 90 days after intervention initiated
measure of quality of life
Time frame: 30 days after intervention initiated
Measure of health status and symptoms
Time frame: 60 days after intervention initiated
measure of health status and symptoms
Time frame: 90 days after intervention initiated
measure of health status and symptoms
Time frame: 30 days after intervention initiated
measure of health care utilization
Time frame: 60 days after intervention initiated
measure of health care utilization
Time frame: 90 days after intervention initiated
measure of health care utilization
University of Nebraska
Other
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