The overall goal of this pilot study is to establish protocols for a clinical trial of the effect of varying levels of nursing intervention on ambulatory blood pressure (ABP) in Stage 1 hypertensives. In addition, the study is designed to identify sensitive ABP measures.
The aims are to: 1) distinguish the ABP effect of enhanced nursing intervention (exercise training, nutrition counseling, stress modulation teaching/counseling) from routine nursing intervention (exercise training, nutrition counseling) and from no nursing intervention; 2) assess the sensitivity of ABP measures; and 3) determine the ABP effect of intervention 8 weeks after intervention ceases. The stress modulation teaching/counseling which distinguishes the enhanced nursing intervention will be conducted by two doctorally prepared advance practice nurses. It is based on previously established clinical protocols designed to modulate stress and thereby lower blood pressure. The sample for this proposed pilot will include 40 subjects with mild (Stage I, unmedicated) hypertension who will receive an 8-week intervention and an 8-week control condition. The order of condition will be randomly assigned. Therefore, 20 subjects will receive 8 weeks of the control condition followed by 8 weeks of intervention and 20 subjects will receive the intervention condition first. While in the intervention condition, subjects will be randomly assigned either to routine or enhanced nursing intervention. Five outcome measures (24-hour mean pressure; day and night mean pressure; BP load; BP variance; 24-hour BP profile) will be derived from the ABP data collected at study entry (baseline), after a control or intervention condition which lasts 8 weeks and 8 weeks after the completion of the intervention condition. For all measures except BP profile, analysis of covariance will be used to compare groups. Baseline ABP will serve as the covariate. BP profile will be analyzed using restricted maximum likelihood estimation. The effect of intervention 8 weeks after intervention ceases will be analyzed using the mixed effects model for repeated measures. Results from these analyses will be available to plan for a clinical trial with adequate power to determine the ambulatory blood pressure effect of the nursing interventions.
| Liehr, Patricia; Meininger, Janet C; Vogler, Robert et al. (2006) Adding story-centered care to standard lifestyle intervention for people with Stage 1 hypertension. Appl Nurs Res 19:16-21 |
