Health Over Time: Longitudinal Design and Models in Nursing Research

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

• 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

• 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

CO

NC

EP

TIO

N

26–30 weeks

28-32 weeks

Testing, Dx of GDM

EligibilityPermissionEnrollment

STUDY WEEKS

1 2 3 4 5 6 7 8

Hgb A1c

Diet Recall

Self-monitored (SMBG)

Blood Glucose

SMBG SMBG SMBG

Diet Recall

HgbAIc

40 WeeksBIRTH

Birth outcomes

SMBG SMBG SMBGSMBG

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

• 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: – 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)

Infant ANS function

Maternal caregiving

ANS Function in Healthy Infants

Social and emotional regulation

Infant ANS function

Maternal caregiving

ANS Function in Infant with Serious Health Condition

Social and emotional regulation

Serious health condition Hospitalization Surgery Multiple caregivers Maternal separation

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

Start feeding

Stress response (HF HRV)

End feeding

State of homeostasis (HF HRV)

• TGA or healthy• Maternal behavior• Time since surgery

Theoretical Model of Response to Feeding

Challenge

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

0

1

2

3

4

5

6

T1 Pre T1 Dur T1 Post T2 Pre T2 Dur T2 Post

HealthyTGA

HF HRV

Healthy: Time 1 During Feeding

MSAW

TGA: Time 1 During Feeding

MSAW

Time 1

Time 1

14%7 %

Time 2 Time 2

19%

40%

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.

Infant ANS function

Maternal caregiving

ANS Function in Infant with Serious Health

Condition

Social and emotional regulation

Serious health condition Hospitalization Surgery Multiple caregivers Maternal separation

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

• 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– 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

Time

FeedingHRV

SSC Intervention

2 weeks

Pre30min

Dur Post60min

Pre30 min

Dur Post60 min

Pre30 min

Dur Post60 min

Time 2Post-

Intervention

Time 3Post-

Intervention

Time 4Post-

Intervention

2 weeks 2 weeks

Pre30min

Dur Post60 min

Time 1Pre-

Intervention

Data Collection

SurveyDiaryMother

Staff nurse

Interviews mid to end of study

Data Analysis

• Descriptive– 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)

Infant stress neurobiology

Maternal caregiving

ANS Function in Infant with Serious Health

Condition

Social and emotional regulation

Serious health condition Hospitalization Surgery Multiple caregivers Maternal separation

Maternal factors: Depression Anxiety

OxytocinPhysical contact HRV

SNS Cortisol

Maternal Support, Attunement, and

Warmth

• 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, UMNCo-I: Amy Williams, M.D., Mayo Clinic

Co-I: Cindy Felty, R.N., Mayo ClinicCo-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 non-weight bearing exercise such as leg cycling may increase blood flow and thus improve oxygenation and healing of ischemic foot ulcers

NEUROPATHY VASCULAR CARDIAC

DIABETES RENAL DISEASE

Perception pain temperature vibration touch

Injury mechanical thermal chemical

sensory motor autonomic

sarcopenia

Alteredgait

Altered foot pressures Sheer stress

calluses

vasomotordysregulation

blood flow

perfusion

cell nutrition

healing

oxidative stress inflammation

endothelialdysfunction

atherosclerosis

LV mass

LV dysfunction preload afterload intropic state chronotropic state

Cardiac output

FOOT ULCER

footdeformitiesweakness

Adapted from Zangaro and Hull,1999and Painter 1988

Pathways of foot ulcer development:Shaded areas are factors

that may be improved with exercise.

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: – cycling exercise during dialysis (3 mo) – usual care

Entry CriteriaInclusion

• Treated with hemodialysis for at least 3 months• 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 CriteriaExclusion

• 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)

Study ImplementationPatient 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– 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