Jeanine Blanchard PhD, OTR/L
Room: CHP 101G
Schepens Niemiec, S. L., Blanchard, J., Vigen, C., Martínez, J., Guzmán, L., Concha, A., Fluke, M., & Carlson, M. (2018). Evaluation of ¡Vivir Mi Vida! to improve health and wellness of rural-dwelling, late middle-aged Latino adults: Results of a feasibility and pilot study of a lifestyle intervention. Primary Health Care Research & Development. Advance online publication. https://doi.org/10.1017/S1463423617000901
Pyatak, E. A., Carandang, K., Vigen, C. L., Blanchard, J., Díaz, J., Concha-Chavez, A., Sequeira, P. A., Wood, J. R., Whittemore, R., Spruijt-Metz, D., & Peters, A. L. (2018). Occupational therapy intervention improves glycemic control and quality of life among young adults with diabetes: The Resilient, Empowered, Active Living With Diabetes (REAL Diabetes) randomized controlled trial. Diabetes Care, 41(4), 696-704. https://doi.org/10.2337/dc17-1634 Show abstract
Objective. To assess the efficacy of a manualized occupational therapy (OT) intervention (Resilient, Empowered, Active Living with Diabetes [REAL Diabetes]) to improve glycemic control and psychosocial well-being among ethnically diverse young adults with low socioeconomic status (SES) who have type 1 or type 2 diabetes.
Research Design and Methods. Eighty-one young adults (age 22.6 ± 3.5 years; hemoglobin A1c [HbA1c] = 10.8%/95 mmol/mol ± 1.9%/20.8 mmol/mol) were randomly assigned to the REAL Diabetes intervention group (IG) or an attention control group (CG) over 6 months. IG participants received biweekly sessions guided by a manual composed of seven content modules; CG participants received standardized educational materials and biweekly phone calls. Blinded assessors collected data at baseline and 6 months. The primary outcome was HbA1c; secondary outcomes included diabetes self-care, diabetes-related quality of life (QOL), diabetes distress, depressive symptoms, and life satisfaction. Change scores were analyzed using Wilcoxon rank sum tests.
Results. Intent-to-treat analyses showed that IG participants showed significant improvement in HbA1c (-0.57%/6.2 mmol/mol vs. +0.36%/3.9 mmol/mol, P = 0.01), diabetes-related QOL (+0.7 vs. +0.15, P = 0.04), and habit strength for checking blood glucose (+3.9 vs. +1.7, P = 0.05) as compared with CG participants. There was no statistically significant effect modification by sex, ethnicity, diabetes type, recruitment site, or SES. No study-related serious adverse events were reported.
Conclusions. The REAL Diabetes intervention improved blood glucose control and diabetes-related QOL among a typically hard-to-reach population, thus providing evidence that a structured OT intervention may be beneficial in improving both clinical and psychosocial outcomes among individuals with diabetes.
Schepens Niemiec, S. L., Blanchard, J., Vigen, C. L., Martínez, J., Guzmán, L., Fluke, M., & Carlson, M. (2018). A pilot study of the ¡Vivir Mi Vida! lifestyle intervention for rural-dwelling, late-midlife Latinos: Study design and protocol. OTJR: Occupation, Participation and Health. Advance online publication. https://doi.org/10.1177/1539449218762728 Show abstract
Older, rural-dwelling Latinos face multiple health disparities. We describe the protocol of a pilot study of a community health worker–occupational therapist-led lifestyle program, ¡Vivir Mi Vida! (¡VMV!), designed for delivery in primary care and adapted for late-midlife, Latino rural-living patients. Using mixed methods, we collected feasibility, acceptability, and preliminary efficacy data on ¡VMV!. Forty 50- to 64-year-old Latinos participated in a 16-week lifestyle intervention led by a community health worker–occupational therapist team. We conducted pre- and post-intervention assessments to evaluate the efficacy of ¡VMV! in improving psychosocial and clinical health outcomes. Focus groups and interviews were held post-intervention with participants and key stakeholders to assess feasibility and acceptability. This is the first trial designed to evaluate a lifestyle intervention that includes collaboration between occupational therapists and community health workers within primary care. The detailed description of methodology promotes research transparency and reproducibility of a community health worker–occupational therapist-led lifestyle intervention.
Carlson, M., Vigen, C. L., Rubayi, S., Blanche, E. I., Blanchard, J., Atkins, M., Bates-Jensen, B., Garber, S. L., Pyatak, E. A., Díaz, J., Floríndez, L. I., Hay, J. W., Mallinson, T., Unger, J. B., Azen, S. P., Scott, M., Cogan, A., & Clark, F. (2017). Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study. Journal of Spinal Cord Medicine. Advance online publication. https://doi.org/10.1080/10790268.2017.1313931 Show abstract
Context/Objective. Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI.
Design. A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group.
Setting. Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County.
Participants. Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group.
Interventions. The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts.
Outcome Measures. Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures.
Results. Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were .56 for intervention recipients, .48 for randomized controls, and .65 for nonrandomized controls. At follow-up, rates were .44 and .39 respectively for randomized intervention and control participants.
Conclusions. Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect.
Trial Registration. ClinicalTrials.gov NCT01999816.
Fogelberg, D. J., Leland, N. E., Blanchard, J., Rich, T. J., & Clark, F. A. (2017). Qualitative experience of sleep in individuals with spinal cord injury. OTJR: Occupation, Participation and Health, 37(2), 89-97. https://doi.org/10.1177/1539449217691978 Show abstract
Poor sleep contributes to adverse health outcomes making it important to understand sleep in medically vulnerable populations, including those with spinal cord injury (SCI). However, little attention has been paid to circumstances specific to SCI that may negatively affect sleep, or to consequences of poor sleep in this population. The objective of this study was to examine the experience of sleep among individuals with SCI. Secondary analysis using thematic coding of qualitative data from an ethnographic study of community-dwelling adults with SCI was conducted. Sleep-related data were found in transcripts for 90% of the sample. Participants described diminished sleep duration and irregular sleep patterns. Several factors contributing to poor sleep were identified, including SCI-related circumstances and sleep environment. Participants also discussed how poor sleep affected occupational engagement. This study highlights the extent of sleep disturbance experienced after SCI and the subsequent impact on occupational performance, and provides direction for clinical practice.
Pyatak, E. A., Carandang, K., Vigen, C., Blanchard, J., Sequeira, P. A., Wood, J. R., Spruijt-Metz, D., Whittemore, R., & Peters, A. L. (2017). Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults. Contemporary Clinical Trials, 54, 8-17. https://doi.org/10.1016/j.cct.2016.12.025 Show abstract
Overview. This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist.
Methods. In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity.
Results. At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence.
Discussion. Participants in the REAL study demonstrate clinically significant medical and psychosocial needs.
Leland, N. E., Fogelberg, D., Sleight, A., Mallinson, T., Vigen, C., Blanchard, J., Carlson, M., & Clark, F. (2016). Napping and nighttime sleep: Findings from an occupation-based intervention. American Journal of Occupational Therapy, 70(4), 7004270010p1-7. https://doi.org/10.5014/ajot.2016.017657 Show abstract
Objective. To describe sleeping behaviors and trends over time among an ethnically diverse group of community-living older adults.
Method. A descriptive secondary data analysis of a subsample (n = 217) from the Lifestyle Redesign randomized controlled trial was done to explore baseline napping and sleeping patterns as well as 6-mo changes in these outcomes.
Results. At baseline, the average time sleeping was 8.2 hr daily (standard deviation = 1.7). Among all participants, 29% reported daytime napping at baseline, of which 36% no longer napped at follow-up. Among participants who stopped napping, those who received an occupation-based intervention (n = 98) replaced napping time with nighttime sleep, and those not receiving an intervention (n = 119) experienced a net loss of total sleep (p < .05).
Conclusion. Among participants who stopped napping, the occupation-based intervention may be related to enhanced sleep. More research examining the role of occupation-based interventions in improving sleep is warranted.
Cogan, A. M., Blanchard, J., Garber, S. L., Vigen, C. L., Carlson, M., & Clark, F. A. (2016). Systematic review of behavioral and educational interventions to prevent pressure ulcers in adults with spinal cord injury. Clinical Rehabilitation, 31(7), 871-880. https://doi.org/10.1177/0269215516660855 Show abstract
Objective. To investigate the efficacy of behavioral or educational interventions in preventing pressure ulcers in community-dwelling adults with spinal cord injury (SCI).
Data Sources. Cochrane, Clinical Trials, PubMed, and Web of Science were searched in June 2016. The search combined related terms for pressure ulcers, spinal cord injury, and behavioral intervention. Each database was searched from its inception with no restrictions on year of publication.
Review Methods. Inclusion criteria required that articles were (a) published in a peer-reviewed journal in English, (b) evaluated a behavioral or educational intervention for pressure ulcer prevention, (c) included community-dwelling adult participants aged 18 years and older with SCI, (d) measured pressure ulcer occurrence, recurrence, or skin breakdown as an outcome, and (e) had a minimum of 10 participants. All study designs were considered. Two reviewers independently screened titles and abstracts. Extracted information included study design, sample size, description of the intervention and control condition, pressure ulcer outcome measures, and corresponding results.
Results. The search strategy yielded 444 unique articles of which five met inclusion criteria. Three were randomized trials and two were quasi-experimental designs. A total of 513 participants were represented. The method of pressure ulcer or skin breakdown measurement varied widely among studies. Results on pressure ulcer outcomes were null in all studies. Considerable methodological problems with recruitment, intervention fidelity, and participant adherence were reported.
Conclusions. At present, there is no positive evidence to support the efficacy of behavioral or educational interventions in preventing pressure ulcer occurrence in adults with SCI.
Clark, F. A., Blanchard, J., Sleight, A., Cogan, A., Eallonardo, L., Floríndez, L., Gleason, S., Heymann, R., Hill, V., Holden, A., Jackson, J. M., Mandel, D. R., Murphy, M., Proffitt, R., Niemiec, S. S., Vigen, C., & Zemke, R. (2015). Lifestyle redesign: The intervention tested in the USC Well Elderly Studies (2nd ed.). Bethesda, MD: American Occupational Therapy Association. Full text Show abstract
Reorganized, expanded, and updated, this new edition of the award-winning Lifestyle Redesign gives practical guidance in this preventative occupational therapy program for independent-living older adults. The work integrates the concept of the USC's landmark Well Elderly Studies, which determined that preventive occupational therapy greatly enhances the health and quality of life of independent-living older adults.
Twelve modules, including those on longevity, stress, home safety and navigating health care, illustrate how to incorporate the program into practice. Includes a flash drive with program handouts.
Ghaisas, S., Pyatak, E. A., Blanche, E., Blanchard, J., & Clark, F. (2015). Lifestyle changes and pressure ulcer prevention in adults with spinal cord injury in the Pressure Ulcer Prevention Study Lifestyle Intervention. American Journal of Occupational Therapy, 69(1), 6901290020p1-6901290020p10. https://doi.org/10.5014/ajot.2015.012021 Show abstract
Pressure ulcers (PrUs) are a major burden to patients with spinal cord injury (SCI), affecting their psychological, physical, and social well-being. Lifestyle choices are thought to contribute to the risk of developing PrUs. This article focuses on the interaction between lifestyle choices and the development of PrUs in community settings among participants in the University of Southern California-Rancho Los Amigos National Rehabilitation Center Pressure Ulcer Prevention Study (PUPS II), a randomized controlled trial of a lifestyle intervention for adults with SCI. We conducted a secondary cross-case analysis of treatment notes of 47 PUPS II participants and identified four patterns relating PrU development to lifestyle changes: positive PrU changes (e.g., healing PrUs) with positive lifestyle changes, negative or no PrU changes with positive lifestyle changes, positive PrU changes with minor lifestyle changes, and negative or no PrU changes with no lifestyle changes. We present case studies exemplifying each pattern.
Mallinson, T., Schepens Niemiec, S. L., Carlson, M., Leland, N., Vigen, C., Blanchard, J., & Clark, F. (2014). Development and validation of the activity significance personal evaluation (ASPEn) scale. Australian Occupational Therapy Journal, 61(6), 384-393. https://doi.org/10.1111/1440-1630.12155 Show abstract
Background/Aim. Engagement in desired occupations can promote health and wellbeing in older adults. Assessments of engagement often measure frequency, amount or importance of specific activities. This study aimed to develop a scale to measure older adults' evaluation of the extent to which their everyday activities are contributing to their health and wellness.
Methods. Eighteen items, each scored with a seven-point rating scale, were initially developed by content experts, covering perceptions of how daily activities contribute to physical and mental health, as well as satisfaction and activity participation in the last six months. Rasch analysis methods were used to refine the scale using the pencil and paper responses of 460 community-living older adults.
Results. Initial Rasch analysis indicated three unlabelled rating scale categories were seldom used, reducing measurement precision. Five items were conceptually different by misfit statistics and principal component analysis. Subsequently, those items were removed and the number of rating scale steps reduced to 4. The remaining 13-item, 4-step scale, termed the Activity Significance Personal Evaluation (ASPEn), formed a unidimensional hierarchy with good fit statistics and targeting. Person separation reliability (2.7) and internal consistency (.91) indicated the tool is appropriate for individual person measurement. Relative validity indicated equivalence between Rasch measures and total raw scores.
Conclusions. ASPEn is a brief, easily administered assessment of older adults' perception of the contribution of everyday activities to personal health and wellness. ASPEn may facilitate occupational therapy practice by enabling clinicians to assess change in meaning of an older adult's activity over time.
Carlson, M., Jackson, J., Mandel, D., Blanchard, J., Holguin, J., Lai, M. Y., Marterella, A., Vigen, C., Gleason, S., Lam, C., Azen, S., & Clark, F. (2014). Predictors of retention among African American and Hispanic older adult research participants in the Well Elderly 2 randomized controlled trial. Journal of Applied Gerontology, 33(3), 357-382. https://doi.org/10.1177/0733464812471444 Show abstract
The purpose of this study was to document predictors of long-term retention among minority participants in the Well Elderly 2 Study, a randomized controlled trial of a lifestyle intervention for community-dwelling older adults. The primary sample included 149 African American and 92 Hispanic men and women aged 60 to 95 years, recruited at senior activity centers and senior residences. Chi-square and logistic regression procedures were undertaken to examine study-based, psychosocial and health-related predictors of retention at 18 months following study entry. For both African Americans and Hispanics, intervention adherence was the strongest predictor. Retention was also related to high active coping and average (vs. high or low) levels of activity participation among African Americans and high social network strength among Hispanics. The results suggest that improved knowledge of the predictors of retention among minority elders can spawn new retention strategies that can be applied at individual, subgroup, and sample-wide levels.
Clark, F., Pyatak, E. A., Carlson, M., Blanche, E. I., Vigen, C., Hay, J., Mallinson, T., Blanchard, J., Unger, J. B., Garber, S. L., Díaz, J., Floríndez, L. I., Atkins, M., Rubayi, S., & Azen, S. P. (2014). Implementing trials of complex interventions in community settings: The USC-Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS). Clinical Trials, 11(2), 218-229. https://doi.org/10.1177/1740774514521904 Show abstract
Background. Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects.
Purpose. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury.
Methods. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes.
Results. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination.
Limitations. We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings.
Conclusions. Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.
Pyatak, E. A., Blanche, E. I., Garber, S. L., Díaz, J., Blanchard, J., Floríndez, L., & Clark, F. A. (2013). Conducting intervention research among underserved populations: Lessons learned and recommendations for researchers. Archives of Physical Medicine and Rehabilitation, 94(6), 1190-1198. https://doi.org/10.1016/j.apmr.2012.12.009 Show abstract
Randomized controlled trials (RCTs) are considered the criterion standard in research design for establishing treatment efficacy. However, the rigorous and highly controlled conditions of RCTs can be difficult to attain when conducting research among individuals living with a confluence of disability, low socioeconomic status, and being a member of a racial/ethnic minority group, who may be more likely to have unstable life circumstances. Research on effective interventions for these groups is urgently needed, because evidence regarding approaches to reduce health disparities and improve health outcomes is lacking. In this methodologic article, we discuss the challenges and lessons learned in implementing the Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury study among a highly disadvantaged population. These issues are discussed in terms of strategies to enhance recruitment, retention, and intervention relevance to the target population. Recommendations for researchers seeking to conduct RCTs among socioeconomically disadvantaged, ethnically diverse populations are provided.
Clark, F. A., Jackson, J. M., Carlson, M. E., Chou, C. P., Cherry, B. J., Jordan-Marsh, M., Knight, B. G., Mandel, D., Blanchard, J., Granger, D. A., Wilcox, R. R., Lai, M. Y., White, B. A., Hay, J. W., Lam, C., Marterella, A., & Azen, S. P. (2012). Effectiveness of a lifestyle intervention in promoting the well-being of independently living older people: Results of the Well Elderly 2 Randomised Controlled Trial. Journal of Epidemiology and Community Health, 66(9), 782-790. https://doi.org/10.1136/jech.2009.099754 Show abstract
Background. Older people are at risk for health decline and loss of independence. Lifestyle interventions offer potential for reducing such negative outcomes. The aim of this study was to determine the effectiveness and cost-effectiveness of a preventive lifestyle-based occupational therapy intervention, administered in a variety of community-based sites, in improving mental and physical well-being and cognitive functioning in ethnically diverse older people.
Methods. A randomised controlled trial was conducted comparing an occupational therapy intervention and a no-treatment control condition over a 6-month experimental phase. Participants included 460 men and women aged 60-95 years (mean age 74.9±7.7 years; 53% < $12,000 annual income) recruited from 21 sites in the greater Los Angeles metropolitan area.
Results. Intervention participants, relative to untreated controls, showed more favourable change scores on indices of bodily pain, vitality, social functioning, mental health, composite mental functioning, life satisfaction and depressive symptomatology (ps < 0.05). The intervention group had a significantly greater increment in quality-adjusted life years (p < 0.02), which was achieved cost-effectively (US $41,218/UK £24,868 per unit). No intervention effect was found for cognitive functioning outcome measures.
Conclusions. A lifestyle-oriented occupational therapy intervention has beneficial effects for ethnically diverse older people recruited from a wide array of community settings. Because the intervention is cost-effective and is applicable on a wide-scale basis, it has the potential to help reduce health decline and promote well-being in older people.
Carlson, M. E., Wilcox, R. R., Chou, C. P., Chang, M., Yang, F., Blanchard, J., Marterella, A., Kuo, A., & Clark, F. A. (2011). Psychometric properties of reverse-scored items on the CES-D in a sample of ethnically diverse older adults. Psychological Assessment, 23(2), 558-562. https://doi.org/10.1037/a0022484 Show abstract
Reverse-scored items on assessment scales increase cognitive processing demands and may therefore lead to measurement problems for older adult respondents. In this study, the objective was to examine possible psychometric inadequacies of reverse-scored items on the Center for Epidemiologic Studies Depression Scale (CES-D) when used to assess ethnically diverse older adults. Using baseline data from a gerontologic clinical trial (n = 460), we tested the hypotheses that the reversed items on the CES-D (a) are less reliable than nonreversed items, (b) disproportionately lead to intraindividually atypical responses that are psychometrically problematic, and (c) evidence improved measurement properties when an imputation procedure based on the scale mean is used to replace atypical responses. In general, the results supported the hypotheses. Relative to nonreversed CES-D items, the 4 reversed items were less internally consistent, were associated with lower item-scale correlations, and were more often answered atypically at an intraindividual level. Further, the atypical responses were negatively correlated with responses to psychometrically sound nonreversed items that had similar content. The use of imputation to replace atypical responses enhanced the predictive validity of the set of reverse-scored items. Among older adult respondents, reverse-scored items are associated with measurement difficulties. It is recommended that appropriate correction procedures such as item readministration or statistical imputation be applied to reduce the difficulties.
Jackson, J. M., Mandel, D., Blanchard, J., Carlson, M. E., Cherry, B. J., Azen, S. P., Chou, C. P., Jordan-Marsh, M., Forman, T., White, B. A., Granger, D., Knight, B. G., & Clark, F. A. (2009). Confronting challenges in intervention research with ethnically diverse older adults: The USC Well Elderly II Trial. Clinical Trials, 6(1), 90-101. https://doi.org/10.1177/1740774508101191 Show abstract
Background. Community-dwelling older adults are at risk for declines in physical health, cognition, and psychosocial well-being. However, their enactment of active and health-promoting lifestyles can reduce such declines.
Purpose. The purpose of this article is to describe the USC Well Elderly II study, a randomized clinical trial designed to test the effectiveness of a healthy lifestyle program for elders, and document how various methodological challenges were addressed during the course of the trial.
Methods. In the study, 460 ethnically diverse elders recruited from a variety of sites in the urban Los Angeles area were enrolled in a randomized experiment involving a crossover design component. Within either the first or second 6-month phase of their study involvement, each elder received a lifestyle intervention designed to improve a variety of aging outcomes. At 4-5 time points over an 18-24 month interval, the research participants were assessed on measures of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the effectiveness of the intervention and document the process mechanisms responsible for its effects.
Results. The study protocol was successfully implemented, including the enrollment of study sites, the recruitment of 460 older adults, administration of the intervention, adherence to the plan for assessment, and establishment of a large computerized data base.
Limitations. Methodological challenges were encountered in the areas of site recruitment, participant recruitment, testing, and intervention delivery.
Conclusions. The completion of clinical trials involving elders from numerous local sites requires careful oversight and anticipation of threats to the study design that stem from: (a) social situations that are particular to specific study sites; and (b) physical, functional, and social challenges pertaining to the elder population.