TruSage International techniques have been proven to generate results. In the services
section, you will find a “bottom up” results analysis in the form of testimonials
from customers. In this section, we provide a “top down” view based on clinical
studies of the TruSage system performed by 3rd parties
Clinical Studies of the TruSage System
Summary
The TruSage System provides personalized coaching to patients to help them maintain
or improve personal health. The TruSage approach is grounded in the principles of
positive psychology, a sub-discipline of psychology that focuses on promoting health
and optimizing human function. TruSage coaching takes the form of personalized,
interactive messages that are delivered to patients via a cost-effective, convenient,
mobile technology platform.
Dr. Brian Alman, who holds a PhD in clinical psychology and is an expert in positive
psychology and behavioral modification, developed the TruSage System. As a provider
for Kaiser Permanente and the Kaiser Permanente Positive Choice Wellness Center,
Dr. Alman has been using the principles of positive psychology and behavioral modification
for over 20 years to help obese patients lose weight and maintain weight loss. Each
week, Dr. Alman supplements the support and feedback he offers during office visits
with several brief telephone calls to each patient to coach them as they make positive
behavioral changes.
To make his telephone coaching available to more patients, Dr. Alman founded TruSage
International, Inc, which has developed an algorithm that generates personalized,
pre-recorded, digital versions of his messages to patients. TruSage System messages
are designed to supplement and extend the efforts of healthcare providers to motivate
patients to maintain and improve their health. These messages are not a substitute
for office visits with healthcare providers.
In 3 clinical studies of the TruSage System in a total of 489 patients, TruSage
messages were associated with reduced use of healthcare services and improved health-related
outcomes, as follows:
1.In an exploratory study, 103 participants reported improved self-care
and increased satisfaction with their healthcare services after receiving TruSage
messages. All participants were high utilizers of
healthcare services.
2. In the Sanford Clinic Study, a comparative study of the TruSage
System in 86 overweight patients enrolled in a nonsurgical weight loss program,
patients who
received TruSage messages lost more weight and dropped
out less often than those in a control group.
3. According to preliminary data from the Positive Wellness Center
Study, a double blind, randomized, comparative clinical study of the TruSage System
in 300
overweight patients, health-related outcomes improved
in patients who received TruSage messages vs those who did not. All patients were
enrolled in a
nonsurgical weight loss program. Analysis of data
from this study is ongoing.
TruSage International welcomes opportunities to conduct additional studies that
may further evaluate and validate the TruSage System’s ability to improve outcomes
in high utilizers of clinical services, overweight patients, and patients with a
variety of other health issues.
Background
Positive psychology is an emerging sub-discipline of psychology that is recognized
for its potential to improve short- and long-term healthcare outcomes for both patients
and healthy individuals. Unlike other branches of psychology, positive psychology
focuses on health and optimization of human function, and not on pathology.
1
A central tenet in positive psychology is that positive experience involves core
attributes, including optimism, subjective well-being, happiness, and self-determination.
2
Importantly, the presence of these attributes is correlated with physical health.
For example, optimism and subjective well-being positively influence biological
processes, including neuroendocrine and immune function, and health-related behaviors,
including risk-taking, self-care, social interaction, and patient compliance.
3,4
Patients expected to benefit the most from positive psychology are those with health
conditions with significant psychological components or that are impacted heavily
by patient behavior.
3 For example, obesity, which is widespread in the
US, increases healthcare costs, and is associated with comorbidities such as type
2 diabetes, hyperlipidemia, and heart disease,
5 has significant psychological
components.
6 An analysis of hundreds of obese patients’ life histories
revealed that obesity often develops as a response to a childhood trauma.
6
Also, many obese patients, consciously or inconsciously, perceive their obesity
as providing them with physical and social benefits.
6
Most approaches to management of obesity have limited efficacy. Changes in physical
activity and nutrition can address many of the physical components of obesity and
weight management, but do not address the important psychological components.
6
Kaiser-Permanente’s Positive Choice Wellness Center has been an innovator in the
treatment of obese patients.
7 During its 20-week weight loss program,
the Center addresses psychological components with weekly support groups led by
trained counselors, and addresses physical components with supervised, supplemented
fasting. Nonetheless, about 50% of patients fail to complete the program, and 47%
of patients who complete the program fail to maintain at least 60% of their weight
loss.
7 Thus, these obese patients may benefit from additional psychological
support, such as that offered by positive psychology-based approaches.
The TruSage System was developed by Brian Alman, who holds a PhD in clinical psychology
and is an expert in positive psychology and behavioral modification.
8,9
In his practice, Dr. Alman meets once weekly with patients in his office to offer
support and advice, and supplements these visits with telephone messages that offer
encouragement, describe experiential solution-focused techniques, and reinforce
patient learning. With the TruSage System’s mobile technology platform, any patient
undergoing a health transition can receive Dr. Alman’s messages via telephone or
other media. The messages are designed to improve outcomes in patients who are undergoing
health transitions. Each week, the TruSage System delivers 1 to 6 brief, interactive
messages that are tailored to meet the individual patient’s specific clinical needs.
The messages address the patient’s quality of life and mental wellness, and are
designed to motivate the patient to maintain and improve his or her health. Consistent
with the concept of self-determination, the patient selects the schedule and technology
for delivery of his or her messages. An algorithm ensures that each pre-recorded
call is unique, so no patient receives the same message twice.
Three clinical studies have evaluated the TruSage System in patients with a variety
of health conditions on the basis of health-related outcomes.
10-12 This
article describes the design and results of these studies.
Clinical Studies of the TruSage System
The TruSage System has been evaluated in an exploratory retrospective study in patients
who made frequent office and emergency department visits (high utilizers of healthcare
services),
10 and 2 prospective, comparative clinical studies in overweight
patients enrolled in nonsurgical weight loss programs, the Sanford Clinic Study
11
and Positive Choice Wellness Center Study.
12 In each of these studies,
use of the TruSage System was clearly associated with positive outcomes in participants.
1. Exploratory Study
In a noncomparative, retrospective study of the TruSage System in patients who were
high utilizers of medical services at Kaiser-Permanente in San Diego, CA,
10
outcome measures included:
• Participants’ report of self-care before and after receiving TruSage
messages
• Participants’ perception of the effect of TruSage messages on
their self-care
• Participants’ satisfaction with their health care services
Participants were included if they were high utilizers of healthcare services, met
once weekly with Dr. Alman in his practice as a clinical psychologist for Kaiser-Permanente
in San Diego, CA for 3 to 60 continuous months between 1994 and 1999, received TruSage
messages during that time, and agreed to participate. Data were collected by independent,
trained surveyors during 4-minute telephone interviews with participants in May
1999. All participants gave informed consent.
Results
Among 300 high utilizers of healthcare services who were eligible, 103 (34%) agreed
to participate in the study. Participants were aged a median of 47.5 years and had
received a mean of 3.5 TruSage messages per week (range 1 to 5 messages per week).
In general, participants indicated that TruSage messages encouraged them to reduce
their use of health care services and increased their satisfaction with these services,
as follows:
• 83 participants (81%) reported an improvement in self-care after
receiving TruSage messages, compared to before. messages
• 71 participants (69%) associated TruSage messages with their improved
self-care.
• More than 90% of participants reported high levels of patient
satisfaction with their health care services after receiving TruSage messages.
2. Sanford Clinic Study
The Sanford Clinic Study
11 was a comparative study that examined outcomes
with the TruSage System in 86 overweight patients enrolled in a 20-week nonsurgical
weight loss program in 2007 or 2008 at the Sanford Clinic in Watertown, SD. All
patients received standard care, which involved supplemented fasting, and a weekly,
2-hour support group meeting with an experienced weight loss counselor. The weight
loss counselor recommended reducing caloric intake, maintaining nutrition, and increasing
physical activity. The study participants were divided in 2 groups:
• TruSage patients (n=24) received 1 to 5 TruSage telephone messages
each week during the weight loss program in addition to standard care
•Control patients (n=62) received standard care only
Patients in the TruSage group gave informed consent, and this portion of the study
received prospective IRB approval. Data regarding patients in the control group
were provided to the investigators retrospectively by Sanford Clinic staff, with
individual identifiers removed. For statistical analysis, p<.05 was considered statistically
significant.
Outcome measures included:
• Net weight loss
• Dropout rates
Results
At baseline, body weights in the TruSage group (mean 250.4 lbs, median 241.0 lbs,
SD 62.2) and control group (mean 236.9 lbs, median 219.0 lbs, SD 53.1) were equivalent,
according to an independent sample t-test (t = -1.01 [df 84], p=.32 [2-tailed]).
The study design did not control for other potential sources of bias.
Patients in the TruSage group lost more weight, on average, and dropped out of the
weight loss program less often than patients in the control group (Figure 1):
• At the end of the program, net weight loss was significantly greater
in patients in the TruSage group than in the control group (based on net reduction
in mean
weight, 42.9 lbs vs. 33.9 lbs, p=.03 [1-tailed]; t = -1.87
[df 84]).
• None of the patients in the TruSage group dropped out of the weight
loss program during the study, compared with 9 patients in the control group (0%
vs. 14.5%
of patients); this difference was statistically significant
on the basis of Fisher’s Exact Test (p=.04 [1-tailed]).
3. Positive Choice Wellness Center
Study
The Positive Choice Wellness Center Study
12 was a prospective, comparative,
randomized, double-blind clinical study of the TruSage System (TruSage group) versus
a control intervention (control group) in a total of 300 overweight patients enrolled
at the Positive Choice Wellness Center, a 20-week weight loss program at Kaiser
Permanente in San Diego, CA.
During the weight loss program, all patients engaged in supplemented fasting and
attended a weekly, 2-hour, support group meeting with an experienced weight loss
counselor. At support group meetings, the counselor recommended reducing caloric
intake, maintaining nutrition, and increasing physical activity. Patients were weighed
at baseline and once weekly during the weight loss program and for 12 months after
completing the program.
In addition to the weight loss program, all patients received 3 telephone messages
each week, as follows:
• TruSage patients received TruSage telephone messages that addressed
psychological components of weight management, not physical components
• Control patients received telephone messages from TruSage International
that were similar to TruSage messages, except the content addressed physical components
of weight management, not psychological components
The TruSage and control messages were designed so investigators could measure the
contributions of both psychological components and TruSage messages to weight management.
Each patient could choose to continue receiving the same type of telephone messages
for an additional 20 weeks after the program ended.
Outcome measures included
• Net weight loss
• Patients’ attendance at support group meetings
• Maintenance of weight loss
Based on a projected total enrolment of 400 patients, this study had 90% power to
detect a small difference between treatment groups (Cohen's D=.20) with α=.05 (Lenth
2006) Thus, P<.05 was considered statistically significant.
Collection of data for this study is complete, but available data regarding outcomes
are preliminary, and data analyses are ongoing.
Preliminary Results
A total of 313 patients were enrolled in the study, fewer than the projected total
enrollment of 400 patients. Of those patients enrolled, 13 patients (4%) withdrew,
primarily because of technical issues with the messaging system, so outcomes were
evaluated in 300 patients. Among the patients evaluated, 82% were women, 72% were
Caucasian, and mean age was 51.1 years. At baseline, mean weights in the evaluated
patients in the TruSage and control groups were similar (216 lbs and 220 lbs, respectively).
Patients in the TruSage group lost more weight, on average, and dropped out of the
weight loss program less often than patients in the control group (Figure 2):
• Patients in the TruSage group lost more weight, on average, than
patients in the control group (31 lbs vs 23 lbs).
• The mean weight of patients in the TruSage group was lower than
that in the control group (210 lbs vs 220 lbs) at about 9 months after completing
the program
(mean of 41 weeks vs 43 weeks, respectively), suggesting that
patients in the TruSage group maintained their weight loss more effectively than
those in the
control group. For this analysis, weights were adjusted to
allow for an observed linear increase in all patients’ weights as a function of
time.
• The TruSage and control groups attended a similar number of support
group meetings (mean of 13.8 and 13.4 meetings during the 20-week weight loss
program, respectively).
Conclusions
The TruSage System offers personalized coaching in the form of interactive messages
via a mobile technology platform to support patients who are undergoing health transitions
or in the process of changing their health-related behavior. It has been evaluated
in clinical studies in a total of 489 patients with various healthcare issues. In
a retrospective study, 103 high utilizers of healthcare services who received TruSage
messages reported improved self-care and greater satisfaction with their healthcare
services.
10 In 2 comparative clinical studies that enrolled 86 patients
11
or 300 patients
12 who were overweight and enrolled in nonsurgical weight
loss programs, the TruSage System improved health-related outcomes.
TruSage International is actively seeking additional opportunities to partner with
investigators to further evaluate and validate the TruSage System in high utilizers
of clinical services and overweight patients in weight loss programs. The company
also wishes to evaluate the effects of the TruSage System on outcomes important
to other patient populations, healthcare providers, and healthcare facilities.
Investigators
Retrospective Study10
Principal Investigator: Wayne Beach, PhD, Professor, School of Communication, San
Diego State University, San Diego, CA
Sanford Clinic Study11
Co-investigator and Biostatistician: David Dozier, PhD, Professor, School of Communication,
San Diego State University, San Diego, CA
Positive Choice Wellness Center Study12
Principal Investigator: Albert Ray, MD, DABFM, CCPF, FAAFP, FCFP, Department of
Preventive Medicine, Kaiser-Permanente Positive Choice Wellness Center, San Diego,
CA
Research Coordinator: Kathy Jakstis, RN, Director, Kaiser-Permanente Positive Choice
Wellness Center, San Diego, CA
Co-investigator and Biostatistician: David Dozier, PhD, Professor, School of Communication,
San Diego State University, San Diego, CA
References
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and (possible) future. Journal of Positive Psychology. 2006;1(1):3-16.
2. Seligman ME, Csikszentmihalyi M. Positive psychology. An introduction. American
Psychologist. 2000;55(1):5-14.
3. Aspinwall LG, Tedeschi RG. The value of positive psychology for health psychology:
progress and pitfalls in examining the relation of positive phenomena
to health. Annals Of Behavioral Medicine. 2010;39(1):4-15.
4. Salovey P, Rothman AJ, Detweiler JB, Steward W. Emotional states and physical
health. American Psychologist. 2000;55(1):110-121.
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Permanente Journal. 2003;7(3):11-20.
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Permanente Journal. 2010;14(1):24-30.
7. Kaiser-Permanente. Positive Choice Wellness Center. Weight Management Program
Options. 2007.
8. Alman B. The Voice. New York, NY: Sterling Publishers; 2011.
9. Alman B. Keep It Off. New York, NY: Penguin Group; 2004.
10. Beach WA, Dozier DM. Caring for health: phone survey of TruSage International:
mobile-assisted learning patients. Unpublished Executive Summary, 2005.
11. Dozier DM. TruSage: Sanford Clinic Watertown Efficacy Study. Unpublished
Executive Summary, 2008.
12. Dozier D, Ray A, Jakstis K. A test of the efficacy of recorded interactive
telephone messages to support a weight loss program. Submitted for publication.