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A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial.

Piette JD, Striplin D, Marinec N, Chen J, Trivedi RB, Aron DC, Fisher L, Aikens JE - J. Med. Internet Res. (2015)

Bottom Line: Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers' needs for information about the patient's status or how the caregiver can help.However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, P<.01), and 10.2% more mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up (P=.048). mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints (both P<.05), were consistently more likely to report taking medications as prescribed during weekly IVR assessments, and also were less likely to report breathing problems or weight gains (all P<.05).Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal caregiver outside the household improved HF patients' medication adherence and caregiver communication. mHealth+CP may also decrease patients' risk of HF exacerbations related to shortness of breath and sudden weight gains. mHealth+CP may improve quality of life among patients with greater depressive symptoms.

View Article: PubMed Central - HTML - PubMed

Affiliation: Center for Clinical Management Research and Center for Managing Chronic Disease, VA Ann Arbor Healthcare System and University of Michigan School of Public Health, Ann Arbor, MI, United States. jpiette@umich.edu.

ABSTRACT

Background: Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers' needs for information about the patient's status or how the caregiver can help.

Objective: We evaluated mHealth support for caregivers of HF patients over and above the impact of a standard mHealth approach.

Methods: We identified 331 HF patients from Department of Veterans Affairs outpatient clinics. All patients identified a "CarePartner" outside their household. Patients randomized to "standard mHealth" (n=165) received 12 months of weekly interactive voice response (IVR) calls including questions about their health and self-management. Based on patients' responses, they received tailored self-management advice, and their clinical team received structured fax alerts regarding serious health concerns. Patients randomized to "mHealth+CP" (n=166) received an identical intervention, but with automated emails sent to their CarePartner after each IVR call, including feedback about the patient's status and suggestions for how the CarePartner could support disease care. Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate. Self-care and symptom data also were collected through the weekly IVR assessments.

Results: Participants were on average 67.8 years of age, 99% were male (329/331), 77% where white (255/331), and 59% were married (195/331). During 15,709 call-weeks of attempted IVR assessments, patients completed 90% of their calls with no difference in completion rates between arms. At both endpoints, composite quality of life scores were similar across arms. However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, P<.01), and 10.2% more mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up (P=.048). mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints (both P<.05), were consistently more likely to report taking medications as prescribed during weekly IVR assessments, and also were less likely to report breathing problems or weight gains (all P<.05). Among patients with more depressive symptoms at enrollment, those randomized to mHealth+CP were more likely than standard mHealth patients to report excellent or very good general health during weekly IVR calls.

Conclusions: Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal caregiver outside the household improved HF patients' medication adherence and caregiver communication. mHealth+CP may also decrease patients' risk of HF exacerbations related to shortness of breath and sudden weight gains. mHealth+CP may improve quality of life among patients with greater depressive symptoms. Weekly health and self-care monitoring via mHealth tools may identify intervention effects in mHealth trials that go undetected using typical, infrequent retrospective surveys.

Trial registration: ClinicalTrials.gov NCT00555360; https://clinicaltrials.gov/ct2/show/NCT00555360 (Archived by WebCite at http://www.webcitation.org/6Z4Tsk78B).

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Related in: MedlinePlus

Unadjusted self-care and health status reports for patients in each randomization group by week since enrollment: Standard mHealth=patients randomized to IVR monitoring and self-care support with clinician alerts; mHealth+CP=patients randomized to the same intervention + weekly feedback to patients’ CarePartners. The Y-axis for each panel differs in scale; bars represent the proportion of patients responding with that report. P values are from logistic regression models testing differences across arms. P values <.05 represent significant effects favoring mHealth+CP. A: Reports of always taking heart failure medication exactly as prescribed in the prior week. B: Reports of being bothered by shortness of breath every day or several days in the prior week. C: Clinically significant weight gain generating a notification to patients’ healthcare team. D: Reports of very good or excellent health (versus good, fair, or poor health) in the prior week.
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figure4: Unadjusted self-care and health status reports for patients in each randomization group by week since enrollment: Standard mHealth=patients randomized to IVR monitoring and self-care support with clinician alerts; mHealth+CP=patients randomized to the same intervention + weekly feedback to patients’ CarePartners. The Y-axis for each panel differs in scale; bars represent the proportion of patients responding with that report. P values are from logistic regression models testing differences across arms. P values <.05 represent significant effects favoring mHealth+CP. A: Reports of always taking heart failure medication exactly as prescribed in the prior week. B: Reports of being bothered by shortness of breath every day or several days in the prior week. C: Clinically significant weight gain generating a notification to patients’ healthcare team. D: Reports of very good or excellent health (versus good, fair, or poor health) in the prior week.

Mentions: Displays of the unadjusted proportion of patients reporting perfect medication adherence, shortness of breath, and concerning weight changes via IVR suggested differences that favored mHealth+CP (Figure 4). These findings were substantiated by logistic regression analyses. Throughout the 1-year intervention, mHealth+CP patients were consistently more likely than standard mHealth patients to report perfect HF medication adherence over the prior week (main effect for arm, ie, ß=.5092; 95% CI 0.0857-0.9329; P=.02). There were no differences in time-trends in adherence reports across arms (P=.41), and the arm-by-time interaction term was excluded from the final model. Based on the logistic model, mHealth+CP patients had an 8.3% absolute greater likelihood of reporting perfect HF medication adherence in the prior week at 6 months (83.7% versus 75.4% for standard mHealth) and a 10.0% greater likelihood at 12 months (84.9% versus 74.9%).


A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial.

Piette JD, Striplin D, Marinec N, Chen J, Trivedi RB, Aron DC, Fisher L, Aikens JE - J. Med. Internet Res. (2015)

Unadjusted self-care and health status reports for patients in each randomization group by week since enrollment: Standard mHealth=patients randomized to IVR monitoring and self-care support with clinician alerts; mHealth+CP=patients randomized to the same intervention + weekly feedback to patients’ CarePartners. The Y-axis for each panel differs in scale; bars represent the proportion of patients responding with that report. P values are from logistic regression models testing differences across arms. P values <.05 represent significant effects favoring mHealth+CP. A: Reports of always taking heart failure medication exactly as prescribed in the prior week. B: Reports of being bothered by shortness of breath every day or several days in the prior week. C: Clinically significant weight gain generating a notification to patients’ healthcare team. D: Reports of very good or excellent health (versus good, fair, or poor health) in the prior week.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4526929&req=5

figure4: Unadjusted self-care and health status reports for patients in each randomization group by week since enrollment: Standard mHealth=patients randomized to IVR monitoring and self-care support with clinician alerts; mHealth+CP=patients randomized to the same intervention + weekly feedback to patients’ CarePartners. The Y-axis for each panel differs in scale; bars represent the proportion of patients responding with that report. P values are from logistic regression models testing differences across arms. P values <.05 represent significant effects favoring mHealth+CP. A: Reports of always taking heart failure medication exactly as prescribed in the prior week. B: Reports of being bothered by shortness of breath every day or several days in the prior week. C: Clinically significant weight gain generating a notification to patients’ healthcare team. D: Reports of very good or excellent health (versus good, fair, or poor health) in the prior week.
Mentions: Displays of the unadjusted proportion of patients reporting perfect medication adherence, shortness of breath, and concerning weight changes via IVR suggested differences that favored mHealth+CP (Figure 4). These findings were substantiated by logistic regression analyses. Throughout the 1-year intervention, mHealth+CP patients were consistently more likely than standard mHealth patients to report perfect HF medication adherence over the prior week (main effect for arm, ie, ß=.5092; 95% CI 0.0857-0.9329; P=.02). There were no differences in time-trends in adherence reports across arms (P=.41), and the arm-by-time interaction term was excluded from the final model. Based on the logistic model, mHealth+CP patients had an 8.3% absolute greater likelihood of reporting perfect HF medication adherence in the prior week at 6 months (83.7% versus 75.4% for standard mHealth) and a 10.0% greater likelihood at 12 months (84.9% versus 74.9%).

Bottom Line: Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers' needs for information about the patient's status or how the caregiver can help.However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, P<.01), and 10.2% more mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up (P=.048). mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints (both P<.05), were consistently more likely to report taking medications as prescribed during weekly IVR assessments, and also were less likely to report breathing problems or weight gains (all P<.05).Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal caregiver outside the household improved HF patients' medication adherence and caregiver communication. mHealth+CP may also decrease patients' risk of HF exacerbations related to shortness of breath and sudden weight gains. mHealth+CP may improve quality of life among patients with greater depressive symptoms.

View Article: PubMed Central - HTML - PubMed

Affiliation: Center for Clinical Management Research and Center for Managing Chronic Disease, VA Ann Arbor Healthcare System and University of Michigan School of Public Health, Ann Arbor, MI, United States. jpiette@umich.edu.

ABSTRACT

Background: Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers' needs for information about the patient's status or how the caregiver can help.

Objective: We evaluated mHealth support for caregivers of HF patients over and above the impact of a standard mHealth approach.

Methods: We identified 331 HF patients from Department of Veterans Affairs outpatient clinics. All patients identified a "CarePartner" outside their household. Patients randomized to "standard mHealth" (n=165) received 12 months of weekly interactive voice response (IVR) calls including questions about their health and self-management. Based on patients' responses, they received tailored self-management advice, and their clinical team received structured fax alerts regarding serious health concerns. Patients randomized to "mHealth+CP" (n=166) received an identical intervention, but with automated emails sent to their CarePartner after each IVR call, including feedback about the patient's status and suggestions for how the CarePartner could support disease care. Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate. Self-care and symptom data also were collected through the weekly IVR assessments.

Results: Participants were on average 67.8 years of age, 99% were male (329/331), 77% where white (255/331), and 59% were married (195/331). During 15,709 call-weeks of attempted IVR assessments, patients completed 90% of their calls with no difference in completion rates between arms. At both endpoints, composite quality of life scores were similar across arms. However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, P<.01), and 10.2% more mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up (P=.048). mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints (both P<.05), were consistently more likely to report taking medications as prescribed during weekly IVR assessments, and also were less likely to report breathing problems or weight gains (all P<.05). Among patients with more depressive symptoms at enrollment, those randomized to mHealth+CP were more likely than standard mHealth patients to report excellent or very good general health during weekly IVR calls.

Conclusions: Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal caregiver outside the household improved HF patients' medication adherence and caregiver communication. mHealth+CP may also decrease patients' risk of HF exacerbations related to shortness of breath and sudden weight gains. mHealth+CP may improve quality of life among patients with greater depressive symptoms. Weekly health and self-care monitoring via mHealth tools may identify intervention effects in mHealth trials that go undetected using typical, infrequent retrospective surveys.

Trial registration: ClinicalTrials.gov NCT00555360; https://clinicaltrials.gov/ct2/show/NCT00555360 (Archived by WebCite at http://www.webcitation.org/6Z4Tsk78B).

Show MeSH
Related in: MedlinePlus