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NRI 04-242 – HSR Study

NRI 04-242
An Intervention to Enhance Function in Severe Cardiopulmonary Illness
Bonnie G. Steele, PhD RN
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, WA
Funding Period: September 2007 - August 2011
Chronic cardiopulmonary illness is a prime contributor to long-term disability and death in veterans and a huge economic burden to VA resources. Exercise improves health in these groups. This study investigated an intervention combining outpatient and home exercise to improve daily activity and function in two elderly, medically fragile groups: veterans with severe chronic obstructive pulmonary disease (COPD) or heart failure (HF).

1.To determine intervention effects on primary outcomes: daily activity, functional capacity, dyspnea and depression
2.To determine intervention effects on secondary outcomes: quality of life, cardiopulmonary function, self-efficacy, and gait/balance.
3.To test the self-efficacy model for mediating effects on primary outcomes.
4.To compare treatment group costs and health care resource utilization.

We hypothesized that after six months, the intervention group would demonstrate improvements in primary and secondary outcomes compared to usual care and would exhibit reduced resource utilization and costs over 12 months.

This randomized controlled trial screened 673 veterans, 89 of whom underwent randomization into either the Intervention [I] (four-weeks of 2 two-hour sessions per week of exercise and self-management education followed by five months of weekly phone calls encouraging home exercise, N= 45) or Usual Care [UC] (eight-weeks, 2 one-hour sessions of exercise and self-management instruction per week, N= 44). Inclusion criteria were: diagnosis of severe COPD or HF with recent hospitalization or unscheduled outpatient visits, phone, and willingness to join an exercise program. Exclusion criteria were: unstable disease or recent surgery, high oxygen needs, already exercising, cannot exercise, uncontrolled mental illness, alcohol or drug abuse, or short life expectancy Primary and secondary outcomes were measured at baseline, six and 12 months: daily activity (Stepwatch Activity Monitor (Orthocare Innovations, LLC), functional capacity (6MWD), dyspnea (Clinical COPD Questionnaire) and depression (Geriatric Depression Scale). Secondary outcomes included cardiopulmonary function (BNP [beta naturietic protein]-HF, FEV1% [forced expiratory volume in 1 second % predicted]-COPD), quality of life and self-efficacy questionnaires and gait/balance assessment. The total sample (N=89) (intent to treat) and a subsample who attended 80% of either intervention (N=64) underwent analysis. For both samples, outcomes were analyzed using a 3 time point (Baseline, 6 and 12 months) repeated measures ANOVA with time/treatment interaction, controlling for age, body mass index (BMI), current smoking, co-morbidities, and miles from VA. Aim 3 used path analysis with primary outcomes and self-efficacy variables. Aim 4 analysis included costs of exercise programs and VA and non-VA healthcare during the 12 month follow-up period. Health care utilization was assessed using the VA Financial Management Decision Support System; non-VA costs were determined by a questionnaire.

This all-male sample included 62 subjects with COPD and 27 with HF, mean age 66 years.
Aim 1: The total sample (N=89), analysis found no significant intervention differences in daily activity, 6MWD, dyspnea and depression at 6 or 12 months. Primary outcomes at 6 months (mean/standard deviation) by treatment group on 6MWD Intervention= 1146 (487) UC=1108 (401) p=0.89; total steps Intervention=5142 (2878) UC=5288 (3407) p=0.64. Primary outcomes at 12 months by treatment group on 6MWD Intervention= 964 (461) UC=1073 (401) p=0.083; total steps Intervention=4713 (2240) UC=5548 (3813) p=0.064. The subsample analysis by compliance noted higher 6MWD and total steps in usual care when compared to the intervention group at 12 months. No differences were evident for dyspnea or depression. Compliance was 80% in the 4 week intervention compared to 64% in usual care.
Aim 2: There were no significant group differences for secondary outcomes (quality of life, cardiopulmonary function, self-efficacy, and gait/balance) in either the total sample or subsample.
Aim 3: Self-efficacy expectations and self-efficacy for walking were associated with higher 6MWD (p=0.001), peak performance (p=0.012), and total steps taken (p=0.006) in both groups. Outcome expectations for exercise did not significantly mediate any of the outcomes. There was no treatment effect on self-efficacy.
Aim 4 The combined exercise and class sessions direct cost per session was $45.35 per patient, phone calls $8.64, tune-up sessions - $32.39; and home visits- $173.85. Usual care patients exercise sessions cost $25.92 each. The total mean direct cost of the entire exercise program per patient for the intervention group was $598.66 and $298.08 for usual care patients. VA care: inpatient and outpatient costs did not differ significantly between groups during the 12 month follow-up period. Non-VA care: A significantly higher percent of patients in the intervention groups (26.7%) reported hospitalizations during the follow-up period compared to usual care (6.8%). There was no difference between groups in self reported non-VA outpatient care.
This study found no significant intervention benefit with regard to primary or secondary outcomes. With an estimated sample size of 200, the study was underpowered at 89; recruitment and retention were markedly compromised by participants' severe illness. Self-efficacy expectations were non-selectively associated with 6MWD and activity. Program costs for both groups were relatively low and comparable to the local community. Non-VA hospitalizations were greater in the intervention group but these findings were difficult to validate and should be interpreted with caution.

There was a trend toward better outcomes in the longer usual care group and the possibility of increased non-VA hospitalizations in the intervention, although the small sample size in this analysis casts doubt on these findings. It is possible that greater intervention benefit may be evident in COPD and HF patients who are less severely ill and better able to participate in an intensive exercise program. The intervention was found to be relatively low in cost, feasible for clinical application, and accepted by study participants. This study was conducted with no treatment-related adverse events in a fragile sample over four years which should encourage implementation of exercise interventions with appropriate safeguards in similar VA populations.

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DRA: Health Systems, Cardiovascular Disease, Lung Disorders
DRE: Treatment - Comparative Effectiveness, Treatment - Observational
Keywords: Behavior (patient), Cost, Utilization patterns
MeSH Terms: none

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