Transcript Slide 1

Health Over Time:
Longitudinal Design and
Models in Nursing Research
P20 Seminar, March 25, 2010
Exercise for American Indian
Women with Gestational Diabetes:
A Pilot Study
Melissa D. Avery, PhD, CNM, FACNM, FAAN
Objective
• At the end of this session, participants will be able to
describe an exercise intervention designed for
American Indian women with gestational diabetes
mellitus.
Background
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Diabetes in US
Diabetes in pregnancy
Diabetes in American Indian population
Exercise in pregnancy
Exercise for GDM
Focus groups and
interviews
• Focus groups, urban and
reservation
• Key informant interviews
• Family and friends
• Culture
• Safety and basic needs
• Variety of exercise modes
Study Aims: Primary
• Test feasibility of the exercise intervention and
pilot a RCT comparing an 8 week exercise
intervention for the treatment of GDM with usual
care in the American Indian community.
Study Aims: Secondary
• Assess differences in self-monitored daily fasting and
post-prandial blood glucose values between the exercise
and usual care groups over the 8 week intervention
• Assess differences in hemoglobin A1c from baseline to
post intervention between exercise and usual care
• Compare proportion of women who require insulin or
other glucose lowering medication between exercise and
usual care
Methods
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Recruitment from multiple local clinics
Randomization to intervention or usual care
Diet recall baseline and 8 weeks
Hgb A1c baseline and 8 weeks
Record book to record daily BGs and exercise and
intensity
• Semi-structured interview at study end
Intervention
• Provider permission
• Twice weekly exercise sessions at local fitness
center
• Two DVDs provided to use at home as desired
• Encouraged to exercise 5 days a week X 30
minutes, low to moderate intensity
28-32
weeks
CONCEPTION
26–30
weeks
40 Weeks
STUDY WEEKS
1
2
3
4
5
6
BIRTH
7
8
SMBG SMBG SMBG SMBG SMBG SMBG SMBG
Testing, Dx
of GDM
Eligibility
Permission
Enrollment
Hgb
A1c
Hgb
AIc
Diet
Recall
Diet
Recall
Self-monitored
(SMBG)
Blood Glucose
Birth
outcomes
Progress to date
• 7 eligible referrals
• 4 participants
recruited
• 3 completed full study
• Continuing to recruit
Questions?
Acknowledgement:
The women who share their time and expertise and our
community partners – Native American Community
Clinic, Community University Health Care Center, Indian
Health Board Clinic, American Indian Family Center and
Hennepin County Medical Center.
A Pilot Study of a Skin-to-Skin Care
Intervention in Infants with
Congenital Heart Defects
Tondi Harrison, PhD, RN,
CPNP
Objective
•
At the end of this session, participants will be
able to describe the relationship between early
experience and social, emotional, and
behavioral outcomes in children.
• Healthy infants have flexibility in their ability to
grow in a range of environments and with a
variety of caregiving styles.
• Infants who begin their lives in a stressful
environment, separated from their mother may
be less flexible in the type of care they require in
order to overcome their early adversity.
(Gribble, 2007)
Program of research
• Purpose: To examine the effect of early
experience on the development of stress
neurobiology in high risk infants
• Population: Full-term infants hospitalized with
life-threatening and/or chronic health condition
• Long term goal: To develop and test nursing
interventions supportive of the infant’s
neurobehavioral development
Hospital Environment
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Health condition
Invasive diagnostic and therapeutic procedures
Multiple caregivers
Separation from mother
Development of stress
neurobiology
• Evolutionary biology: The infant adapts
physiologically to the early (expected)
environment (Shonkoff, Boyce, & McEwen, 2009)
• Maternal depression, poverty, maltreatment,
deprivation
– Changes in HPA activity (Field et al., 1988; Gunnar &
Chisholm, 1999)
– Elevated cardiac reactivity (Dawson & Ashman, 2000)
– Inflammation (Danese et al., 2007)
• Gene - environment interactions
Outcomes of Early
Adverse Experience
Behavioral health
• Social attachment disturbances, difficulty with
emotional regulation (Wismer Fries et al., 2008)
• Disruptive behavior, anxiety, depression
(Dawson & Ashman, 2000; Gunnar & Vasquez, 2006; reviewed in Pine & Cohen, 2002)
Physical and mental health
• Higher prevalence of cardiovascular, respiratory, and
psychiatric disorders, cancer, alcoholism, drug abuse
(reviewed in Shonkoff, Boyce, & McEwen, 2009)
Hospitalized children
• Outcomes include PTSD (Rennick & Rashotte, 2009;
Schnyder et al., 2001)
Role of Caregiving
• Physiologic stress responses mediated by
attachment security
(Nachmias et al., 1996)
• Early disruptions in parent-child relationship
produced increased cortisol levels which
predicted increased behavioral and
emotional problems
(Essex et al., 2002)
• Sensitivity of caregiving, rather than
amount, is critical in modulating infant stress
response
(Lewis & Ramsay, 1999, Nachmias et al., 1996)
Autonomic Nervous
System Function
• Regulating physiologic processes in order to:
– maintain homeostasis
– respond to challenges to homeostasis
• Serves as the foundation for ability to regulate
behavior and emotion (self-regulation)
ANS: Heart Rate
Variability
• Minute changes in the intervals between beats
• Reflects interaction between sympathetic and
parasympathetic divisions of the ANS
• In general, higher levels of HRV reflect healthy,
responsive ANS function
• Different processes cause changes in heart
rate; operate at different frequencies
• HF HRV primarily reflects parasympathetic
function
– Predominant in states of homeostasis
– Reduced when sympathetic activity needed
Autonomic Regulation
of Feeding
• During infancy, the process of ingesting food is a
challenge to homeostasis.
• During ingestion, parasympathetic stimulation
reduced.
• During digestion, parasympathetic stimulation
increased.
• Monitoring parasympathetic function provides a
way of assessing capacity for responding to
stress.
(Doussard-Roosevelt & Porges, 1999, Porges, 1996)
Theoretical Framework
Development of self-regulation:
Allan Schore
– Maternal interactions with her infant affect
development of sympathetic and parasympathetic
nervous system of ANS.
– The patterns of stimulation of ANS determines
subsequent social and emotional behavior.
Infants with Complex
Congenital Heart Defects
• 36,000 infants born each year with congenital heart
defects
• Impaired ANS function
• Problems regulating social and emotional behavior:
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Inattention
Impulsivity
Anxiety
Depression
Aggression
(Hovels-Gurich et al., 2007; Shillingford et al., 2008)
Mothers of Infants
with CHD
• Interactions between mothers and infants
with CHD are qualitatively different than
interactions between mothers and healthy
infants.
(Gardner et al., 1996; Lobo, 1992)
ANS Function in Healthy
Infants
Maternal
caregiving
Infant ANS
function
Social and
emotional
regulation
ANS Function in Infant with
Serious Health Condition
Serious health condition
Hospitalization
Surgery
Multiple caregivers
Maternal separation
Maternal
caregiving
Infant ANS
function
Social and
emotional
regulation
Preliminary Study
• To examine ANS function in infants with
transposition of the great arteries (TGA) and in
healthy infants
• To examine the effect of maternal behavior
during feeding on ANS function
Theoretical Model of
Response to Feeding
Challenge
• TGA or healthy
• Maternal behavior
• Time since surgery
State of
homeostasis
(HF HRV)
Start
feeding
Stress
response
(HF HRV)
End
feeding
Sample/Measures
• 15 full-term infants with TGA
• 16 full-term healthy infants
– Matched by age, gender, and feeding type
• Heart Rate Variability
– High frequency power (HF HRV)
• Parent-Child Early Relational Assessment (Clark,
1999)
– Maternal support, attunement, & warmth (MSAW)
HF HRV at Each Feeding Phase by Group
6
5
4
Healthy
TGA
3
HF
HRV
2
1
0
T1 Pre
T1 Dur
T1 Post
T2 Pre
T2 Dur
T2 Post
Healthy: Time 1 During Feeding
MSAW
TGA: Time 1 During Feeding
MSAW
Time 1
Time 1
14%
7%
Time 2
Time 2
40%
19%
Study 1: Conclusions
• Infants with TGA differ from healthy infants in their ability to
regulate physiologic processes in the early weeks after
surgery.
• Maternal sensitivity to her infant during caregiving may be
supportive of developing ANS function, especially in the early
weeks of life.
• Research is needed to identify ways of enhancing the
regulatory effect of maternal behavior in infants with CHDs.
ANS Function in Infant
with Serious Health
Condition
Serious health condition
Hospitalization
Surgery
Multiple caregivers
Maternal separation
Maternal
caregiving
Infant ANS
function
Social and
emotional
regulation
P20 Feasibility Study
Aims
1. To examine feasibility, acceptability, and safety
of skin-to-skin intervention in newborn infants
diagnosed with a complex congenital heart
defect
2. To describe infant ANS function after surgical
intervention across phases of feeding biweekly
over six weeks in infants with CCHD who have
received SSC intervention.
Hospital Environment
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Health condition
Invasive diagnostic and therapeutic procedures
Multiple caregivers
Separation from mother
Skin-to-skin care
• Preterms – improvements in:
– ANS function
– Regulation of respiration
– Regulation of sleep
– Regulation of state
– Organization of responses to visual and auditory stimuli
(Feldman & Eidelman, 2007; Ludington-Hoe, et al., 2004;
2006)
• Infants with CCHD
– Improved cardiorespiratory status (Gazzolo et al., 2000)
• Mothers
– More sensitive caregiving (Feldman et al., 2003)
Aim 1: Research
Questions
• Research question 1: Will participating mothers
adhere to the SSC intervention and be retained
through the completion of the study?
• Research question 2: Will participating mothers find
the study procedures acceptable?
• Research question 3: Will infants with CCHD safely
experience SSC by staying within physician-defined
cardiorespiratory parameters during SSC?
Aim 2: Research
Questions
• Research question 1: How does ANS function
change across phases of feeding?
• Research question 2: To what extent do patterns of
ANS function across phases of feeding differ among
the four observations?
Sample
• 10 infant-mother dyads
• Cardiac defect requiring palliative or corrective
surgery within first 30 days of life.
• Two recruitment sites
• Two staff nurses from each site
SSC Intervention
• Infant stable, started on oral feedings
• One hour daily for 14 consecutive days
• Between feedings
Measures
• Feasibility
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Recruitment & retention
Direct observation of SSC by researcher
Diary completed daily by mother
Staff nurse semi-structured interview
• Acceptability
– Diary completed daily by mother
– Survey at completion of intervention
• Satisfaction
• Experiences
• Suggestions
• Safety: Monitoring adverse events
• Infant ANS function: HF HRV
Data Collection
SSC
Intervention
Time
Feeding
HRV
Time 1
PreIntervention
Pre
30
min
Dur
Post
60
min
Interviews mid
to end of study
Time 2
PostIntervention
Pre
30
min
Diary
Mother
Staff
nurse
2 weeks
Dur
Survey
Post
60
min
2 weeks
Time 3
PostIntervention
Pre
30
min
Dur
Post
60
min
2 weeks
Time 4
PostIntervention
Pre
30
min
Dur
Post
60
min
Data Analysis
• Descriptive
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n (%) recruited/retained
% adherence (frequency and duration of SSC)
survey items reported with means (SD) or %
n (%) adverse events
content analysis of survey items, staff nurse interviews
plot HRV trajectories
event history analysis (post feeding HRV recovery)
ANS Function in Infant
with Serious Health
Condition
Maternal factors:
Depression
Anxiety
Maternal
caregiving
Oxytocin
Physical
contact
Serious health condition
Hospitalization
Surgery
Multiple caregivers
Maternal separation
Infant stress
neurobiology
HRV
SNS
Cortisol
Social and
emotional
regulation
Maternal Support,
Attunement, and
Warmth
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Sensitivity & responsivity
Flexibility
Structuring & mediating environment
Lack of intrusiveness
Consistency & predictibility
Positive affect
Lack of depression or withdrawn mood
Visual contact
Warm & kind tone of voice
Amount of verbalization
A Pilot Study of Cycling Exercise
and Wound Healing in
Diabetic ESRD Patients
PI: Patricia Painter, Ph.D., FACSM, UMN
Co-I: Amy Williams, M.D., Mayo Clinic
Co-I: Cindy Felty, R.N., Mayo Clinic
Co-I: Diane Treat-Jacobson, R.N., Ph.D
Objective
• At the end of this session, participants will be
able to describe the rationale behind the pilot
study.
Background:
The Problem
• Lower extremity amputation (LEA) in patients with
peripheral arterial disease or diabetes typically is the
result of ischemic foot ulcers
• Fifty to 80% of all lower extremity amputations (LEA) in
the U.S. are attributed to diabetes resulting from lower
extremity ulcers
• The incidence of LEA is greater in patients with end
stage renal disease (ESRD) than the general population
and patients with ESRD due to diabetes mellitus (DM)
have 10 times greater incidence of LEA (i.e. 20-22%)
than the general DM population.
Background:
The Problem
• Over 50% of patients with ESRD in the U.S.
have DM
• There is a 63% mortality rate over 2 years
following amputation in patients with ESRD
• The problem of diabetic foot ulcer and LEA is a
major concern in patients with ESRD
Background: Treatment
• Treatment of non-critical ischemia (claudication) should
include preventive foot care, smoking cessation and
exercise
• When these interventions fail to relieve symptoms,
patients are usually offered revascularization and/or
medications
• Most patients with ESRD 20 to DM are not candidates for
surgery
• Most patients with ESRD are treated by nephrologists
and may not receive preventive foot care and, in the U.S.
most patients with ESRD are not provided counseling or
opportunity for exercise
Hypothesis
• Since cardiovascular exercise increases blood flow
and oxygenation to the working muscles.
• It is, thus, reasonable to hypothesize that nonweight bearing exercise such as leg cycling may
increase blood flow and thus improve oxygenation
and healing of ischemic foot ulcers
Pathways of foot ulcer development:
Shaded areas are factors
that may be improved with exercise.
DIABETES
RENAL DISEASE
NEUROPATHY
s ens ory
Perception
pain
temperature
vibration
touch
Injury
mechanical
thermal
chemical
motor
VASCULAR
autonomic
weakness
oxidative stress
inflammation
vasomotor
dysregulation
sarcopenia
foot
deformities
Altered
gait
Altered foot pressures
Sheer stress
calluses
FOOT ULCER
CARDIAC
blood flow
perfusion
cell nutrition
healing
endothelial
dysfunction
atherosclerosis
LV mass
LV dysfunction
preload
afterload
intropic state
chronotropic state
Cardiac output
Adapted fromZangaro and Hull,1999
and Painter 1988
Specific Aims
• 1) To determine if patients with ESRD secondary to
diabetes with ischemic foot ulcers can complete a 12 week
program of cycling during the hemodialysis treatment.
• 2) To determine if changes in ischemic foot ulcer size can be
detected in diabetic ESRD patients over 12 weeks of cycling
exercise.
• 3) To determine if changes in physiological measures of
oxygenation and perfusion can be detected in diabetic ESRD
patients with ischemic foot ulcers over 12 weeks of cycling
exercise.
Study design
• Quasi-experimental pre-post design with two
groups:
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cycling exercise during dialysis (3 mo)
usual care
Entry Criteria
Inclusion
• Treated with hemodialysis for at least 3 months
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Diagnosis of diabetes (type I or type II)
Age <90
Non-infected ischemic foot ulcer < 10 cm2
Duration of ulcer at least 4 weeks
Ankle-Brachial Blood Pressure Index <4
TcPO2 in the supine position 20-30 mmHg
Not a candidate for revascularization
Able to perform cycling exercise
Able to perform physical function tests
Able to understand and speak English
Able to understand and provide consent
Entry Criteria
Exclusion
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Previous amputations
Osteomyelitis
Tunneling of the wound
Joint/tendon involvement
Acute occlusion wound
Foot ulcer in a location that would not be exacerbated by
cycling exercise
• No orthopedic or musculoskeletal conditions that may be
exacerbated by exercise
• No contraindications to exercise as determined by the
American Heart Association and American College of
Sports Medicine
Intervention:
Cycling during dialysis work up to 30-45 min
at low intensity (near free-wheeling) for 3 months
Outcome measures
• Wound Healing
– Measurement of wound size using digital
photography: area of wound determined using sigma
scan
• Measured every 2 weeks
Outcome measures
• Physiological Determinants of Wound Healing
– Tissue Oxygenation
• TcPO2 (in horizontal position; 30o above horizontal and
dependent in the seated position
– Tissue Perfusion
• Laser Doppler will measure skin blood flow velocity in the
area of the wound
– Sensory Motor Function
• Sensation detection using the Semmes-Weinstein
monofilament test
Outcome measures
• Physical Functioning
– Short Physical Performance Battery
• Standing Balance
• 4 m gait speed
• Sit to stand test
– Shuttle Walk Test
– Self-Reported Physical Functioning (SF-36)
– Katz Activities of Daily Living Questionnaire
Outcome measures
• Quality of Life
– Kidney Disease Quality of Life (KDQOL)
• SF-36
• + 8 scales that are dialysis specific
Implementation Steps
• IRB: both UMN and at Mayo
– UMN completed March, 2090
– Mayo completed October 2090 (Mayo MD is PI on it)
(application and approval as research collaborator)
• Nephrology in-service
• Mayo Dialysis Staff In-service
• Recruitment of UMN-R nursing students to assist
with exercise training and wound care management
– Present at class (Dec. 2009)
– Get interested students to an orientation (Jan. 22, 2010)
– Need to be ‘certified’ by Mayo
• Classified as ‘interns’ by Mayo
• Certified in several areas
– (infection control, HIPAA, etc
• IRB training (Feb. 1, 2010)
Implementation Steps
• Students:
– Interested initially: 12
– Attended Orientation: 15
– Completed IRB training by Feb 1: 4
• Training:
– Exercise supervision/meet with dialysis staff: 2.5 hours + one
supervised session w/ patient
– Physical function & sensory measures training (2.5 hours)
– Wound clinic training (4 hours - ongoing)
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Study Implementation
Patient Recruitment
Started Feb 1 2010
Referred to date:
Feb 1: n=7
1- discontinued dialysis
1 - has unstable angina at rest
2- wounds had healed
2- signed consent
1- started home dialysis
Feb 22: 1 pt : wound healed
1 pt: came back to unit from home dx
(baseline tested & started with exercise!!!)
March 1: 2 patients referred
1- baseline tested: started exercise
1- going to wound clinic for
stabilization of wound - start ex April 1
March 12: 4 more pt at different clinic referred
Study Subjects
• Subject #1: 56 yo male
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Insulin Dependent DM
March 2008: LVAD placement
Dec 11 2008: heart transplant
Dec 12 2008: kidney transplant - initiated dialysis June 2009
• Physical functioning:
– Unable to stand up from chair without use of arms
– Uses walker for gait speed
– Completed only 4 laps on shuttle walk =peak gait speed of .6 mph
• Starting level of exercise: 2 minutes 1 min rest 2
minutes
• As of March 19: 24 minutes with 4- 1 minute breaks
– Goal to get strong enough to travel to Greece in December!
Study Subjects
• Subject #2: 55 y female
– Insulin Dependent DM
– Vision significantly impaired
– Initiated dialysis October 2005 - not on transplant list
• Physical functioning:
– Unable to stand up from chair without use of arms
– Has Charcot’s joint: gait speed in lowest quartile
– Completed only 5 laps on shuttle walk =peak gait speed of .6 mph
• Starting level of exercise: 7 minutes; 1 min rest; 5
minutes
• As of March 19: 10 minutes with 2- 1 minute breaks
• Used to work as a surgery technician and ride bikes
outside until her vision deteriorated
PLAN
• Continue to recruit subjects as possible
• May need to add Minneapolis VA as a second site