BACKGROUND/RATIONALE:
Patients treated at Veterans Affairs (VA) medical centers are older and have multiple chronic conditions. Two of the most common conditions in the VA population are hypertension (HTN) and Type 2 diabetes (DM). Unfortunately, DM and HTN have few perceptible symptoms on a daily basis to motivate patients to comply with treatment recommendations and lifestyle changes. Thus, serious complications and long-term adverse outcomes are common in both of these conditions. Home telehealth is a general term used to describe the delivery of health care services to the patient's home using audio, video, or other telecommunications technologies. Although home telehealth offers a number of theoretical advantages, few well-designed controlled clinical trials have been conducted to establish efficacy and cost benefit. Furthermore, projects to date have focused on special populations, e.g., heart failure or mental illnesses. Since home telehealth may hold the most promise for individuals dealing with multiple chronic illnesses, there is a need for population-based studies addressing the needs of patients in primary care settings. Care coordination, as defined by the VHA Office of Care Coordination, is a process of assessment and ongoing monitoring of patients using home telehealth to proactively enable prevention, investigation, and treatment that enhances the health of patients and prevents unnecessary and inappropriate use of resources. Care coordination embeds technology into a care management process. This results in the right care, at the right time, in the right place.

OBJECTIVE(S):
The primary objective of this study was to evaluate the efficacy of remote monitoring with nurse care management in improving outcomes in veterans with co-morbid diabetes and hypertension, the two most common chronic conditions seen in Veterans Affairs Primary Care clinics. The primary outcomes were glycemic control (A1c) and systolic blood pressure (SBP).

METHODS:
302 subjects were randomized to three groups: low-intensity monitoring plus nurse care management intervention (n=102); high-intensity monitoring plus nurse care management intervention (n=93); and usual care (n=107). In both intervention groups patients transmitted vital signs daily. In addition, the low intensity group answered two health questions each day; the high intensity group responded to a complete range of questions focused on diabetes and hypertension, and received educational tips. The intervention groups participated in the protocol for 6 months following enrollment.

FINDINGS/RESULTS:
A1c

The three groups were comparable at baseline for mean A1c (7.1, 7.2, 7.1) for control, low, and high intensity, respectively. At 6 months the control group mean A1c was unchanged but the low- and high-intensity groups had dropped significantly (to 6.8 and 6.7 respectively) (F=4.24, p=0.02). From 6 months (following withdrawal of the intervention) to 12 months, the control group had a small but significant decrease (7.1 to 6.9) while both intervention groups increased (6.8 to 7.0 for the low-intensity and 6.7 to 6.9 for the high-intensity groups; p<0.05).

We then analyzed changes for subjects with A1c greater than 7% at baseline (n=99), there were no significant differences from baseline to 6 months across the three groups. However, from 6 months to 12 months, both intervention groups A1c increased (7.5 to 7.7 for the low-intensity and 7.3 to 7.7 for the high-intensity groups) while the control group decreased from 8.0 to 7.5 (p=0.008).

Systolic Blood Pressure

The three groups were comparable at baseline for mean systolic blood pressure (SBP) (134, 134, 139) for control, low, and high intensity respectively). At 6 months there was a significant time by group interaction, i.e., control and low-intensity subjects had increases (+4.0 for control and +0.7 for low-intensity), but the high-intensity subjects dropped by 6.7 points (F=6.01, p=0.001). This pattern was maintained at 12-months; control and low-intensity groups had mean increases of 3.7 and 1.4 mmHg respectively, while the high-intensity group had an overall mean decrease of 5.2 mmHg.

We then analyzed subjects with a baseline SBP greater than 130 mmHg. In this uncontrolled SBP group (n=155 with a SBP of greater than 130) (n's of 59, 45, 51 in control, low, and high intensity respectively) there were no significant differences at either time period (baseline to 6 months or 6 to 12 months). Interestingly, all groups decreased from baseline to 6 months and increased from 6 to 12 months, for an overall decrease from baseline to 12 months. However, the mean SBP for all three groups remained above 130 at 12 months.

Combined Outcomes

We then calculated the effect of the intervention on the combined outcomes of A1c and SBP. The percent of subjects in each group who had both an A1c of 7% or less and SBP of 130 or lower were calculated and compared. There were no significant differences at baseline; 24%, 25%, and 23% of usual care, low, and high intensity respectively were in control on both measures. At 6-months, 19%, 28%, and 36% of usual care, low, and high intensity respectively were in control on both measures (chi square 6.19, df2, p=0.05). At 12-months 22%, 20%, and 31% of usual care, low, and high intensity respectively were in control on both measures (NS). Thus, these results indicate that the intervention was most effective in improving combined outcomes in the high intensity group immediately following the conclusion of the intervention. While the high-intensity group had a higher percentage of subjects in control at 12-months relative to the other two groups, this difference was not statistically significant.

Adherence improved over time for all three groups, but there were no differences among the groups. Subject engagement with data entry via the telehealth device was not different between two intervention groups. Subjects in the low Intensity group entered data a mean 125 days / 182 days (69%); the high Intensity entered data a mean 127 days / 182 days (70%).

IMPACT:
To our knowledge this is the first randomized controlled study to evaluate differing intervention intensity levels in patients with co-morbid conditions. Testing interventions that focus on multiple outcomes is critical. Simultaneous control of both glucose and blood pressure is critical in patients with diabetes. In our study only 24, 27 and 23 percent of all subjects had simultaneous control of A1c and SBP across the three study time points. These rates compare unfavorably with estimates from the larger veteran population, where 31% had simultaneous control of A1c, SBP, and LDL-C. Finally, we assessed longer-term outcomes after the intervention was withdrawn. For both A1c and SBP, intervention subjects worsened from 6 to 12 months. This supports the need for ongoing monitoring for this patient population. Widespread implementation of home monitoring of chronic conditions (primarily diabetes, hypertension, heart failure, COPD, and mental illness) in the VA over the past several years has greatly decreased utilization although no data have been published on clinical outcomes.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Boren S, Wakefield BJ, Dohrmann M. Chronic heart failure consumer information: an exploratory study. AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium. 2008 Nov 6; 884. [view]
2. Gardner SE, Hillis SL, Frantz RA. Clinical signs of infection in diabetic foot ulcers with high microbial load. Biological Research For Nursing. 2009 Oct 1; 11(2):119-28. [view]
3. Rantz MJ, Skubic M, Alexander G, Popescu M, Aud MA, Wakefield BJ, Koopman RJ, Miller SJ. Developing a comprehensive electronic health record to enhance nursing care coordination, use of technology, and research. Journal of gerontological nursing. 2010 Jan 12; 36(1):13-7. [view]
4. Wakefield BJ, Holman JE, Ray A, Scherubel M, Adams MR, Hillis SL, Rosenthal GE. Effectiveness of home telehealth in comorbid diabetes and hypertension: a randomized, controlled trial. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2011 May 1; 17(4):254-61. [view]
5. Young LB, Foster L, Silander A, Wakefield BJ. Home telehealth: patient satisfaction, program functions, and challenges for the care coordinator. Journal of gerontological nursing. 2011 Nov 1; 37(11):38-46. [view]
6. Wakefield BJ, Scherubel M, Ray A, Holman JE. Nursing interventions in a telemonitoring program. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2013 Mar 1; 19(3):160-5. [view]
7. Wakefield BJ, Holman JE, Ray A, Scherubel M, Adams MR, Hills SL, Rosenthal GE. Outcomes of a home telehealth intervention for patients with diabetes and hypertension. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2012 Oct 1; 18(8):575-9. [view]
8. Wakefield BJ, Holman JE, Ray A, Scherubel M. Patient perceptions of a remote monitoring intervention for chronic disease management. Journal of gerontological nursing. 2011 Apr 1; 37(4):16-20. [view]
9. Wakefield BJ, Mentes J, Holman JE, Culp K. Postadmission dehydration: risk factors, indicators, and outcomes. Rehabilitation Nursing : The Official Journal of The Association of Rehabilitation Nurses. 2009 Sep 1; 34(5):209-16. [view]

Conference Presentations

1. Wakefield BJ, Holman JE, Ray A, Scherubel M, Simons M, Kienzle M, Hillis SL, Rosenthal GE. A comparison of low- and high-intensity monitoring in veterans with co-morbid diabetes and hypertension. Presented at: VA HSR&D National Meeting; 2008 Feb 12; Baltimore, MD. [view]
2. Wakefield BJ. A comparison of low- and high-intensity remote monitoring in veterans. Paper presented at: American Telemedicine Association Annual Meeting; 2008 Apr 7; Seattle, WA. [view]
3. Wakefield BJ. A comparison of low-and high-intensity remote monitoring in veterans. Paper presented at: Midwest Nursing Research Society Annual Conference; 2009 Mar 27; Minneapolis, MN. [view]
4. Wakefield BJ. Assessing nurse patient communication using telephone and interactive video. Paper presented at: American Telemedicine Association Annual Meeting; 2004 May 1; Tampa, FL. [view]
5. Wakefield B, Holman JE, Ray A, Griffieon L. Assessing nurse patient communication using telephone and interactive video. Paper presented at: VA Care Coordination and Telehealth Leadership Annual Forum; 2005 Apr 6; Salt Lake City, UT. [view]
6. Koch G, Wakefield BJ, Wakefield D. Assessing Self Care Burden in Patients with Multiple Chronic Conditions. Poster session presented at: Midwest Nursing Research Society Annual Conference; 2013 Mar 8; Chicago, IL. [view]
7. Wakefield BJ. Caregiving in Chronic Illness. Paper presented at: VA Supporting Veterans At Home Conference; 2010 Jul 13; Arlington, VA. [view]
8. Wakefield BJ. Efficacy of Remote Monitoring in Patients with Co-morbid Diabetes and Hypertension. Paper presented at: AcademyHealth Annual Research Meeting; 2010 Jun 28; Boston, MA. [view]
9. Wakefield B. The evidence base for care coordination and home telehealth. Paper presented at: VA Care Management Annual Conference; 2005 Apr 27; Minneapolis, MN. [view]

DRA: Health Systems Science
DRE: none
Keywords: Management, Nursing, Organizational issues, Quality assurance, improvement, Research method, Telemedicine
MeSH Terms: Nursing Care, Telemedicine, Diabetes Mellitus