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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 reports of excellent/very good health for patients in each randomization group by baseline CES-D depression score. Higher scores indicated greater depressive symptoms.
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figure5: Unadjusted reports of excellent/very good health for patients in each randomization group by baseline CES-D depression score. Higher scores indicated greater depressive symptoms.

Mentions: Among patients randomized to standard mHealth, there was a strong negative association between higher (ie, worse) baseline CES-D depression scores and patients’ likelihood of reporting excellent health via IVR (see Figure 5). In contrast, IVR reports of excellent health status were roughly constant in the mHealth+CP arm, regardless of the patient’s baseline level of depressive symptoms. The leveling of mHealth+CP patients’ perceived health reports across baseline CESD-levels reflected a somewhat lower proportion of mHealth+CP patients reporting excellent/very good health relative to standard mHealth patients when baseline CES-D scores were low, as well as a substantially higher proportion reporting excellent/very good health among those with greater baseline depressive symptoms. In multivariate analyses examining the effect of arm on patients’ likelihood of reporting excellent health status separately in groups with low CES-D (scores 0-4) and high baseline CES-D (5+) scores, the effect of mHealth+CP was significant in both groups. mHealth+CP had a positive effect among patients with higher baseline CES-D scores (ß=1.27; 95% CI 0.42-2.12; P<.01), and a smaller negative effect among patients with lower baseline CES-D scores (ß=-.46; CI -0.90 to -0.028; P=.04). According to these models, patients with a baseline CES-D score of 1 were 11% less likely to report excellent/very good health if randomized to mHealth+CP, while patients with a baseline CES-D score of 8 were 22% more likely to report excellent/very good health if randomized to mHealth+CP relative to the control group.


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 reports of excellent/very good health for patients in each randomization group by baseline CES-D depression score. Higher scores indicated greater depressive symptoms.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

figure5: Unadjusted reports of excellent/very good health for patients in each randomization group by baseline CES-D depression score. Higher scores indicated greater depressive symptoms.
Mentions: Among patients randomized to standard mHealth, there was a strong negative association between higher (ie, worse) baseline CES-D depression scores and patients’ likelihood of reporting excellent health via IVR (see Figure 5). In contrast, IVR reports of excellent health status were roughly constant in the mHealth+CP arm, regardless of the patient’s baseline level of depressive symptoms. The leveling of mHealth+CP patients’ perceived health reports across baseline CESD-levels reflected a somewhat lower proportion of mHealth+CP patients reporting excellent/very good health relative to standard mHealth patients when baseline CES-D scores were low, as well as a substantially higher proportion reporting excellent/very good health among those with greater baseline depressive symptoms. In multivariate analyses examining the effect of arm on patients’ likelihood of reporting excellent health status separately in groups with low CES-D (scores 0-4) and high baseline CES-D (5+) scores, the effect of mHealth+CP was significant in both groups. mHealth+CP had a positive effect among patients with higher baseline CES-D scores (ß=1.27; 95% CI 0.42-2.12; P<.01), and a smaller negative effect among patients with lower baseline CES-D scores (ß=-.46; CI -0.90 to -0.028; P=.04). According to these models, patients with a baseline CES-D score of 1 were 11% less likely to report excellent/very good health if randomized to mHealth+CP, while patients with a baseline CES-D score of 8 were 22% more likely to report excellent/very good health if randomized to mHealth+CP relative to the control group.

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