Technologically Enhanced Coaching (TEC):A Program for Improving Diabetes Outcomes
Phase: NA
Conditions: Diabetes
Sponsor: VA Office of Research and Development

Technologically Enhanced Coaching (TEC): A Program for Improving Diabetes Outcomes 
NCT01855399 
Protocol 
6/4/12 

Measures and Data Collection 
Overview 
Measurement will occur at baseline, 6 months (at the completion of the intervention), and 12 months 
after enrollment. Variables chosen for measurement are based on our conceptual framework (Section 
3.4.1). At baseline, 6 months, and 12 months, patients (participants and peer mentors) will complete a 
written survey and assessments of A1c and blood pressure. Patients will receive $25 for each 
assessment they complete. To understand features of successful vs. less successful peer partnerships, 
we will conduct semi-structured telephone interviews at 6 months of a purposive sample of participants 
and mentors in both study arms (choosing a sample with high rates of contact and a sample with low 
rates of contact). Using standard qualitative methods for identifying key themes in participant’s 
experiences with this new program, we will identify central themes from these interviews associated 
with the success of the peer relationships and in meeting intervention goals. Participants and peer 
mentors in the peer mentor +iDecide arm will be asked about their experiences with iDecide and how 
use of the program affected their subsequent contacts and activities (e.g., setting and meeting ‘action 
plan’ goals, effectively raising questions and concerns with PCPs). Quantitative information about use of 
the IVR system will be collected via computerized records that the system maintains of all contacts with 
dates and time durations of all contacts as well as of attempted contacts. To assess peer mentors’ 
experiences, we will conduct semi-structured interviews with a purposive sample of peer mentors with 
differing rates of participation (e.g., those who made regular contact with their assigned peers vs. those 
who did not).  
3.6.2  Description of Measures by Aim 
Aim 1: Test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving 
glucose control relative to peer support alone. At baseline, 6 months, and 12 months, a trained staff 
member will measure patients' A1c, using a Bayer DCA 2000+ analyzer, a portable analyzer producing 
A1c assays in approximately six minutes using finger stick blood samples. These assays have a test 
coefficient of variation (CV, measure of test precision) <5% as required by the National Diabetes Data 
Group and accurately measure A1c levels.[78] The DCA 2000 is reliable, easy to use, and much less 
burdensome to patients than venous blood draws. Our team has familiarity with the DCA 2000 from our 
prior studies.[40,56] To ensure quality control, venous A1c samples will be drawn from 5% of 
participants and analyzed at the Detroit VA’s lab. 
For our “usual care” observed group, we will use CDW data to measure A1c levels. More than 85% of 
diabetes patients who meet our eligibility criteria receive A1c testing at recommended intervals, which 
should ensure adequate numbers of patients with follow-up A1c levels in our control sample. For those 
with missing A1c data, we will use several approaches to examine possible biases (see section 3.7.5). 
Aim 2: Assess the impact of the intervention on blood pressure and medication adherence as well as on 
key patient-centered outcomes, including patients’ satisfaction and involvement with care, perceived 
social support, and diabetes-specific quality of life. These measures will be assessed at baseline, 6 
months, and 12 months. We will measure blood pressure using an Omron® automatic blood pressure 

m o nit or wit h m e m or y a n d t a k e t h e av er a g e of t h e t w o r e a di n gs f oll o wi n g A m eric a n H e art Ass oci ati o n 
g ui d eli n es. (I d e all y w e w o ul d als o m e as ur e li pi d l ev els, b ut h a v e n ot f o u n d s uffici e ntl y r eli a bl e p oi nt -of -
s ervic e m ac hi n es f or t h es e m e as ur e m e nts. At b as eli n e w e will c oll ect i nf or m ati o n o n m ost r ec e nt L DL, 
H DL, a n d t ot al c h ol est er ol l e v els fr o m el ectr o nic m e dic al r ec or ds. If t h er e ar e n o r ec e nt v al u es, t h e 
i D eci d e pr o gr a m t ext i n t h at s ecti o n will e m p h asiz e t h e i m p ort a nc e of h avi n g t h es e ris k f act or l e v els 
c h ec k e d.) T h e b as eli n e a n d 6-m o nt h s ur v eys will t ak e a p pr oxi m at ely 2 5 mi n ut es t o c o m pl et e, a n d t h e 
1 2 -m o nt h s urv e y will t ak e a p pr oxi m at ely 1 5 mi n ut es. M e as ur es f or t h e  k ey p ati e nt -c e nt er e d o utc o m es 
ar e:  
T h e H e alt h -C ar e Cli m at e Q u esti o n n air e ( H C C Q) (t w elv e it e ms). T h e H e alt h -C ar e Cli m at e Q u esti o n n air e 
( H C C Q) (= 0. 8 2) ass ess es p ati e nts' p erc e pti o ns of t h e d e gr e e t o w hic h t h e y ex p eri e nc e t h eir h e alt h -c ar e 
pr o vi d ers ( or t h e ir p e er m e nt or) t o b e a ut o n o my s u p p ortiv e v ers us c o ntr olli n g i n pr o vi di n g g e n er al 
h e alt h s u p p ort or wit h r es p ect t o a s p ecific h e alt h -c ar e iss u e. It w as ori gi n ally v ali d at e d i n a st u dy of 
p ati e nts visiti n g t h eir pri m ar y -c ar e p hysici a ns, w as us e d i n a p u blis h e d st u dy of o b es e p ati e nts 
p artici p ati n g i n a w ei g ht -l oss pr o gr a m, h as si nc e b e e n us e d i n m ulti pl e st u di es of pr of essi o n al a n d l ay 
h e alt h c ar e s u p p ort ers, a n d a v ersi o n t h at i ncl u d es six it e ms m e as uri n g pr actic al s u p p ort f or di a b et es 
s elf-m a n a g e m e nt h as si nc e b e e n v ali d at e d i n t w o st u di es. [ 7 9] W e will as k p artici p a nts t o c o m pl et e t his 
a b o ut t h eir P C P at b as eli n e, six -m o nt hs, a n d 1 2 -m o nt hs. P artici p a nts will c o m pl et e t his ass ess m e nt 
a b o ut t h eir p e er m e nt or at six m o nt hs.  
I nv olv e m e nt i n C ar e D ecisi o ns (fiv e it e ms). T o ass ess c h a n g es i n h o w i nv ol v e d p ati e nts f e el t h ey ar e i n 
di a b et es g o al a n d tr e at m e nt d ecisi o n -m aki n g wit h t h eir h e alt h c ar e pr o vi d ers, w e will us e t h e g o al -
s etti n g s u bsc al e of t h e P ati e nt Ass ess m e nt of C hr o nic Ill n ess C ar e ( P A CI C).[ 8 0] 
 
Di a b et es -S p ecific S oci al S u p p ort (t w elv e it e ms). T o ass ess p erc eiv e d di a b et es -s p ecific s u p p ort w e will 
us e t h e Di a b et es S u p p ort Sc al e ( D S S), a 1 2 -it e m sc al e d e v el o p e d t o ass ess w h et h er a n I nt er n et-b as e d 
di a b et es s u p p ort gr o u p c h a n g e d p artici p a nts’ p erc e pti o ns of  s oci al s u p p ort, s oci al n et w or k siz e, or 
act u al pr ovisi o n of s u p p ort ( α > 0. 9 0). T h e i nstr u m e nt c orr el at es wit h ill n ess i ntr usi v e n ess a n d s elf -c ar e 
b e h avi ors a n d is r es p o nsiv e t o i nt erv e nti o n eff ects.[ 8 1]  
 
Di a b et es -S p ecific Distr ess (t w o it e ms). T his i nstr u m e nt c a pt ur es t h e p ati e nt’s p ers p ecti v e o n t h e 
e m oti o n al b ur d e n of di a b et es a n d its tr e at m e nt.[ 8 2] It h as c o nsist e ntl y hi g h i nt er n al r eli a bilit y wit h a 
Cr o n b ac h’s α of 0. 9 0 a n d g o o d c o nv er g e nt v ali dit y wit h a m e as ur e of g e n er al psyc h ol o gic al distr ess 
(r =.6 3). It is als o ass oci at e d wit h c h a n g es i n A 1c a n d ot h er o utc o m es ov er ti m e. I n a r evi e w of s ev e n 
eff ectiv e di a b et es i nt erv e nti o n st u di es, m e a n sc or es i m pr ov e d fr o m b as eli n e t o f oll o w u p i n all 
st u di es.[ 8 3]   
 
Ai m 3: I d e ntify p ati e nt c h ar act eristics ass oci at e d wit h e n g a g e m e nt i n t h e i nt erv e nti o n a n d m e di at ors 
a n d m o d er at ors of t h e i nt er v e nti o n’s i m p act o n p ati e nt o utc o m es.  
T a bl e 2 pr es e nts t h e m e as ur es w e will us e t o ass ess f act ors w e hy p ot h esiz e m a y b e ass oci at e d wit h 
willi n g n ess t o e n g a g e i n t h e i nt erv e nt i o n ( w hic h m a y als o b e m o d er at ors) a n d m e di at ors a n d 

moderators of intervention effects as well as time points at which we will measure each of these. We 
include measures found to be significant mediators and moderators of effects in our P2P RCT.[40,84] 
  
Mediators 
 Time Points* 
Original Source 
Medication-taking Self-efficacy  1, 2 
Perceived Competence Scale[85] 
 
Autonomous Motivation 
 1, 2 
Treatment Self-Regulation Questionnaire (TSRQ[85] 
 
Medication adherence  1,2 
Morisky Medication Adherence Measure[86] 
 
Assessment of level and type of support received by Peer coach      2 
Process measures used in P2P 
and by Robert Wood Johnson Foundation Diabetes Initiative [40] 
Self-efficacy for shared decision-making with providers  1,2 
 Self-efficacy for Decision-making 
scale[87] 
 
Medication doses and insulin starts 
 1,2 
Survey items and electronic medical records 
Moderators/Engagement Factors 
 
 
Race 
 1 
2010 US Census measures 
Preferred and actual decision-making with providers 
 1 
Preferred and Actual Participation in 
Decision-making Scales[88] 
 
Attachment Style 
 1 
Relationship Questionnaire[89] 
 
Perceived Need for DM self-management support 
 1 
Support Needs Scale from Diabetes 
Care Profile[90] 
 
Perceived Benefits and Barriers to Taking DM medications 
 1 
Two subscales from instrument 
assessing perceived barriers to and benefits from taking diabetes medications based on health beliefs 
model[91] 
 
Health Literacy  1 
Functional Health Literacy Screener[18] 
 
Numeracy 
 1 
Subjective Numeracy Scale (SNS)[92] 
 

Food insecurity  1 
Food Security Survey Module [93]  
 
Neighborhood Safety, Availability of Healthy Foods, and Walking Environment 
 1 
Neighborhood 
Safety Measure, Availability of Healthy Foods, Walking Environment [94] 
 
*Time point 1 is baseline, 2 is at 6 months, 3 is at 12 months. 
 
We will measure standard demographic information including age, gender, and marital status. Socio-
economic status (SES) will be measured using highest grade in school completed, income, and 
household size. We will collect data on diabetes duration and whether all diabetes care is received at VA 
and distance Veteran travels to Detroit VA. We will also collect data on any adverse symptoms 
experienced during the study period such as hypoglycemic symptoms or episodes, although have had no 
hypoglycemic episodes in our prior peer support interventions. Data on diabetes-related complications 
and other co-morbidities will be drawn from EMRs.