Health Over Time: Longitudinal Design and Models in Nursing Research

1. Health Over Time: Longitudinal Design and Models in Nursing Research • P20 Seminar, March 25, 2010

2. Exercise for American Indian Women with Gestational Diabetes: A Pilot Study • Melissa D. Avery, PhD, CNM, FACNM, FAAN

3. 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.

4. Background • Diabetes in US • Diabetes in pregnancy • Diabetes in American Indian population • Exercise in pregnancy • Exercise for GDM

5. Focus groups and interviews • Focus groups, urban and reservation • Key informant interviews • Family and friends • Culture • Safety and basic needs • Variety of exercise modes

6. 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.

7. 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

8. 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

9. 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

10. 26–30 weeks 40 Weeks BIRTH 28-32 weeks STUDY WEEKS CONCEPTION 8 6 7 2 3 4 5 1 SMBG SMBG SMBG SMBG SMBG SMBG SMBG Hgb AIc Hgb A1c Testing, Dx of GDM • Birth outcomes Diet Recall • Eligibility • Permission • Enrollment Diet Recall Self-monitored (SMBG) Blood Glucose

11. Progress to date • 7 eligible referrals • 4 participants recruited • 3 completed full study • Continuing to recruit

12. 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.

13. A Pilot Study of a Skin-to-Skin Care Intervention in Infants with Congenital Heart Defects • Tondi Harrison, PhD, RN, CPNP

14. 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.

15. 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)

16. 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

17. Hospital Environment • Health condition • Invasive diagnostic and therapeutic procedures • Multiple caregivers • Separation from mother

18. 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

19. 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)

20. 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)

21. 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)

22. 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

23. 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)

24. 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.

25. 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)

26. 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)

27. ANS Function in Healthy Infants Social and emotional regulation Maternal caregiving Infant ANS function

28. ANS Function in Infant with Serious Health Condition Serious health condition Hospitalization Surgery Multiple caregivers Maternal separation Social and emotional regulation Maternal caregiving Infant ANS function

29. 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

30. Theoretical Model of Response to Feeding Challenge • TGA or healthy • Maternal behavior • Time since surgery State of homeostasis (HF HRV) Stress response (HF HRV) Start feeding End feeding

31. 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)

32. HF HRV at Each Feeding Phase by Group 6 5 4 Healthy 3 TGA 2 1 0 T1 Pre T1 Dur T1 Post T2 Pre T2 Dur T2 Post HF HRV

33. Healthy: Time 1 During Feeding MSAW TGA: Time 1 During Feeding MSAW

34. Time 1 Time 1 14% 7 %

35. Time 2 Time 2 40% 19%

36. 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.

37. ANS Function in Infant with Serious Health Condition Serious health condition Hospitalization Surgery Multiple caregivers Maternal separation Social and emotional regulation Maternal caregiving Infant ANS function

38. P20 Feasibility Study Aims • To examine feasibility, acceptability, and safety of skin-to-skin intervention in newborn infants diagnosed with a complex congenital heart defect • 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.

39. Hospital Environment • Health condition • Invasive diagnostic and therapeutic procedures • Multiple caregivers • Separation from mother

40. 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)

41. 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?

42. 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?

43. 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

44. SSC Intervention • Infant stable, started on oral feedings • One hour daily for 14 consecutive days • Between feedings

45. 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

46. 2 weeks 2 weeks Time 1 Pre-Intervention Time 2 Post-Intervention Time 3 Post-Intervention Time 4 Post-Intervention Pre 30 min Pre 30 min Pre 30 min Pre 30 min Dur Dur Dur Dur Post 60 min Post 60 min Post 60 min Post 60 min Data Collection SSC Intervention 2 weeks Time Feeding HRV Diary Survey Mother Staff nurse Interviews mid to end of study

47. 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)

48. HRV SNS Cortisol Oxytocin Physical contact ANS Function in Infant with Serious Health Condition Serious health condition Hospitalization Surgery Multiple caregivers Maternal separation Maternal factors: Depression Anxiety Maternal caregiving Infant stress neurobiology Social and emotional regulation

49. 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

50. 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