Browsing by Author "Yancy, William S"
Now showing 1 - 12 of 12
Results Per Page
Sort Options
Item Open Access A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.(Annals of internal medicine, 2016-01) Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene ZBackground
Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused.Objective
To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes.Design
Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740).Setting
Department of Veterans Affairs Medical Center in Durham, North Carolina.Participants
30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis.Intervention
The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record.Measurements
The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes.Results
At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ.Limitation
The study was conducted in a single Veterans Affairs medical center.Conclusion
The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis.Primary funding source
Department of Veterans Affairs, Health Services Research and Development Service.Item Open Access A randomized controlled trial to evaluate the effectiveness of CouPLES: a spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol.(Preventive medicine, 2013-01) Voils, Corrine I; Coffman, Cynthia J; Yancy, William S; Weinberger, Morris; Jeffreys, Amy S; Datta, Santanu; Kovac, Stacey; McKenzie, Jamiyla; Smith, Rose; Bosworth, Hayden BObjective
This randomized controlled trial evaluated the effectiveness of a telephone-delivered, spouse-assisted lifestyle intervention to reduce patient LDL-C.Method
From 2007 to 2010, 255 outpatients with LDL-C>76 mg/dL and their spouses from the Durham Veterans Affairs Medical Center were randomized to intervention or usual care. The intervention comprised nine monthly goal-setting telephone calls to patients and support planning calls to spouses. Outcomes were assessed at 11 months.Results
Patients were 95% male and 65% White. LDL-C did not differ between groups (mean difference = 2.3 mg/dL, 95% CI = -3.6, 8.3, p = 0.44), nor did the odds of meeting goal LDL-C (OR = 0.95, 95% CI = 0.6, 1.7; p = 0.87). Intakes of calories (p = 0.03), total fat (p = 0.02), and saturated fat (p = 0.02) were lower for the intervention group. Cholesterol and fiber intake did not differ between groups (p = 0.11 and 0.26, respectively). The estimated rate of moderate intensity physical activity per week was 20% higher in the intervention group (IRR = 1.2, 95% CI = 1.0, 1.5, p = 0.06). Most participants did not experience a change in cholesterol medication usage during the study period in the intervention (71.7%) and usual care (78.9%) groups.Conclusion
This intervention might be an adjunct to usual primary care to improve adherence to lifestyle behaviors.Item Open Access Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management.(BMC musculoskeletal disorders, 2014-12) Allen, Kelli D; Bosworth, Hayden B; Chatterjee, Ranee; Coffman, Cynthia J; Corsino, Leonor; Jeffreys, Amy S; Oddone, Eugene Z; Stanwyck, Catherine; Yancy, William S; Dolor, Rowena JBackground
The Patient and PRovider Interventions for Managing Osteoarthritis (OA) in Primary Care (PRIMO) study is one of the first health services trials targeting OA in a multi-site, primary care network. This multi-site approach is important for assessing generalizability of the interventions. These analyses describe heterogeneity in clinic and patient characteristics, as well as recruitment metrics, across PRIMO study clinics.Methods
Baseline data were obtained from the PRIMO study, which enrolled n = 537 patients from ten Duke Primary Care practices. The following items were examined across clinics with descriptive statistics: (1) Practice Characteristics, including primary care specialty, numbers and specialties of providers, numbers of patients age 55+, urban/rural location and county poverty level; (2) Recruitment Metrics, including rates of eligibility, refusal and randomization; (3) Participants' Characteristics, including demographic and clinical data (general and OA-related); and (4) Participants' Self-Reported OA Treatment Use, including pharmacological and non-pharmacological therapies. Intraclass correlation coefficients (ICCs) were computed for participant characteristics and OA treatment use to describe between-clinic variation.Results
Study clinics varied considerably across all measures, with notable differences in numbers of patients age 55+ (1,507-5,400), urban/rural location (ranging from "rural" to "small city"), and proportion of county households below poverty level (12%-26%). Among all medical records reviewed, 19% of patients were initially eligible (10%-31% across clinics), and among these, 17% were randomized into the study (13%-21% across clinics). There was considerable between-clinic variation, as measured by the ICC (>0.01), for the following patient characteristics and OA treatment use variables: age (means: 60.4-66.1 years), gender (66%-88% female), race (16%-61% non-white), low income status (5%-27%), presence of hip OA (26%-68%), presence both knee and hip OA (23%-61%), physical therapy for knee OA (24%-61%) and hip OA (0%-71%), and use of knee brace with metal supports (0%-18%).Conclusions
Although PRIMO study sites were part of one primary care practice network in one health care system, clinic and patient characteristics varied considerably, as did OA treatment use. This heterogeneity illustrates the importance of including multiple, diverse sites in trials for knee and hip OA, to enhance the generalizability and evaluate potential for real-world implementation.Trial registration
Clinical trial registration number
NCT 01435109.Item Open Access Do diabetic veterans use the Internet? Self-reported usage, skills, and interest in using My HealtheVet Web portal.(Telemed J E Health, 2010-06) Cho, Alex H; Arar, Nedal H; Edelman, David E; Hartwell, Patricia H; Oddone, Eugene Z; Yancy, William SOBJECTIVE: The Veterans Health Administration has developed My HealtheVet (MHV), a Web-based portal that links veterans to their care in the veteran affairs (VA) system. The objective of this study was to measure diabetic veterans' access to and use of the Internet, and their interest in using MHV to help manage their diabetes. MATERIALS AND METHODS: Cross-sectional mailed survey of 201 patients with type 2 diabetes and hemoglobin A(1c) > 8.0% receiving primary care at any of five primary care clinic sites affiliated with a VA tertiary care facility. Main measures included Internet usage, access, and attitudes; computer skills; interest in using the Internet; awareness of and attitudes toward MHV; demographics; and socioeconomic status. RESULTS: A majority of respondents reported having access to the Internet at home. Nearly half of all respondents had searched online for information about diabetes, including some who did not have home Internet access. More than a third obtained "some" or "a lot" of their health-related information online. Forty-one percent reported being "very interested" in using MHV to help track their home blood glucose readings, a third of whom did not have home Internet access. Factors associated with being "very interested" were as follows: having access to the Internet at home (p < 0.001), "a lot/some" trust in the Internet as a source of health information (p = 0.002), lower age (p = 0.03), and some college (p = 0.04). Neither race (p = 0.44) nor income (p = 0.25) was significantly associated with interest in MHV. CONCLUSIONS: This study found that a diverse sample of older VA patients with sub-optimally controlled diabetes had a level of familiarity with and access to the Internet comparable to an age-matched national sample. In addition, there was a high degree of interest in using the Internet to help manage their diabetes.Item Open Access Food preferences and weight change during low-fat and low-carbohydrate diets.(Appetite, 2016-08-01) McVay, Megan A; Voils, Corrine I; Geiselman, Paula J; Smith, Valerie A; Coffman, Cynthia J; Mayer, Stephanie; Yancy, William SUNLABELLED: Understanding associations between food preferences and weight loss during various effective diets could inform efforts to personalize dietary recommendations and provide insight into weight loss mechanisms. We conducted a secondary analysis of data from a clinical trial in which participants were randomized to either a 'choice' arm, in which they were allowed to select between a low-fat diet (n = 44) or low-carbohydrate diet (n = 61), or to a 'no choice' arm, in which they were randomly assigned to a low-fat diet (n = 49) or low-carbohydrate diet (n = 53). All participants were provided 48 weeks of lifestyle counseling. Food preferences were measured at baseline and every 12 weeks thereafter with the Geiselman Food Preference Questionnaire. Participants were 73% male and 51% African American, with a mean age of 55. Baseline food preferences, including congruency of food preferences with diet, were not associated with weight outcomes. In the low-fat diet group, no associations were found between changes in food preferences and weight over time. In the low-carbohydrate diet group, increased preference for low-carbohydrate diet congruent foods from baseline to 12 weeks was associated with weight loss from 12 to 24 weeks. Additionally, weight loss from baseline to 12 weeks was associated with increased preference for low-carbohydrate diet congruent foods from 12 to 24 weeks. Results suggest that basing selection of low-carbohydrate diet or low-fat diet on food preferences is unlikely to influence weight loss. Congruency of food preferences and weight loss may influence each other early during a low-carbohydrate diet but not low-fat diet, possibly due to different features of these diets. CLINICAL TRIAL REGISTRY: NCT01152359.Item Open Access Hypertension Improvement Project (HIP): study protocol and implementation challenges.(Trials, 2009-02-26) Dolor, Rowena J; Yancy, William S; Owen, William F; Matchar, David B; Samsa, Gregory P; Pollak, Kathryn I; Lin, Pao-Hwa; Ard, Jamy D; Prempeh, Maxwell; McGuire, Heather L; Batch, Bryan C; Fan, William; Svetkey, Laura PBackground
Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care.Methods and design
This paper describes the protocol of a nested 2 x 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months.Discussion
Overall, 8 practices (4 per treatment group), 32 physicians (4 per practice; 16 per treatment group), and 574 patients (289 control and 285 intervention) were enrolled. Baseline characteristics of patients and providers and the challenges faced during study implementation are presented. The HIP interventions may improve blood pressure control and lower cardiovascular disease risk in a primary care practice setting by addressing key components of the chronic care model. The study design allows an assessment of the effectiveness and cost of physician and patient interventions separately, so that health care organizations can make informed decisions about implementation of 1 or both interventions in the context of local resources.Trial registration
ClinicalTrials.gov identifier NCT00201136.Item Open Access Outcome by Gender in the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere Weight Management Program.(Journal of women's health (2002), 2018-01) Batch, Bryan C; Goldstein, Karen; Yancy, William S; Sanders, Linda L; Danus, Susanne; Grambow, Steven C; Bosworth, Hayden BBackground
Few evaluations of the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere (MOVE!) weight management program have assessed 6-month weight change or factors associated with weight change by gender.Materials and methods
Analysis of administrative data from a national sample of veterans in the VA MOVE!Program
Results
A total of 62,882 participants were included, 14.6% were women. Compared with men, women were younger (49.6 years [standard deviation, SD, 10.8] vs. 59.3 years [SD, 9.8], p < 0.0001), less likely to be married (34.1% vs. 56.0%, p < 0.0001), and had higher rates of post-traumatic stress disorder (26.0% vs. 22.4%, p < 0.0001) and depression (49.3% vs. 32.9%, p < 0.001). The mean number of MOVE! visits attended by women was lower than men (5.6 [SD, 5.3] vs. 6.0 [SD, 5.9], p < 0.0001). Women, compared with men, reported lower rates of being able to rely on family or friends (35.7% vs. 40.8%, p < 0.0001). Observed mean percent change in weight for women was -1.5% (SD, 5.2) and for men was -1.9% (SD, 4.8, p < 0.0001). The odds of ≥5% weight loss were no different for women (body-mass index [BMI] >25 kg/m2) compared with men (BMI >25 kg/m2; odds ratio, 1.05 [95% confidence interval, 0.99-1.11; p = 0.13]).Conclusions
Women veterans lost less weight overall compared with men. There was no difference in the odds of achieving clinically significant weight loss by gender. The majority of women and men enrolled lost <5% weight despite being enrolled in a lifestyle intervention. Future studies should focus on identifying program- and participant-level barriers to weight loss.Item Open Access Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials.(BMC musculoskeletal disorders, 2012-04) Allen, Kelli D; Bosworth, Hayden B; Brock, Dorothea S; Chapman, Jennifer G; Chatterjee, Ranee; Coffman, Cynthia J; Datta, Santanu K; Dolor, Rowena J; Jeffreys, Amy S; Juntilla, Karen A; Kruszewski, Jennifer; Marbrey, Laurie E; McDuffie, Jennifer; Oddone, Eugene Z; Sperber, Nina; Sochacki, Mary P; Stanwyck, Catherine; Strauss, Jennifer L; Yancy, William SBackground
Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care.Methods / design
One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed.Discussion
Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings.Trial registration
NCT01130740 (VA); NCT 01435109 (NIH).Item Open Access Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.(Annals of internal medicine, 2017-03) Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena JBackground
A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions.Objective
To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes.Design
Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109).Setting
10 Duke University Health System community-based primary care clinics.Participants
537 outpatients with symptomatic hip or knee osteoarthritis.Intervention
The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers.Measurements
The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups.Results
No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care.Limitations
The study involved 1 health care network. Data on provider referrals were not collected.Conclusion
Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care.Primary funding source
National Institute of Arthritis and Musculoskeletal and Skin Diseases.Item Open Access Prevalence of and characteristics associated with insomnia and obstructive sleep apnea among veterans with knee and hip osteoarthritis.(BMC musculoskeletal disorders, 2018-03) Taylor, Shannon Stark; Hughes, Jaime M; Coffman, Cynthia J; Jeffreys, Amy S; Ulmer, Christi S; Oddone, Eugene Z; Bosworth, Hayden B; Yancy, William S; Allen, Kelli DBackground
Few studies have examined patterns of specific sleep problems among individuals with osteoarthritis (OA). The primary objective of this study was to examine prevalence of symptoms of insomnia and obstructive sleep apnea (OSA) among Veterans with OA. Secondary objectives were to assess proportions of individuals with insomnia and OSA symptoms who may have been undiagnosed and to examine Veterans' characteristics associated with insomnia and OSA symptoms.Methods
Veterans (n = 300) enrolled in a clinical trial completed the Insomnia Severity Index (ISI) and the Berlin Questionnaire (BQ) at baseline; proportions of participants with symptoms consistent with insomnia and OSA were calculated, using standard cut-offs for ISI and BQ. For Veterans with insomnia and OSA symptoms, electronic medical records were searched to identify whether there was a diagnosis code for these conditions. Multivariable linear (ISI) and logistic (BQ) regression models examined associations of the following characteristics with symptoms of insomnia and OSA: age, gender, race, self-reported general health, body mass index (BMI), diagnosis of post-traumatic stress disorder (PTSD), pain severity, depressive symptoms, number of joints with arthritis symptoms and opioid use.Results
Symptoms consistent with insomnia and OSA were found in 53 and 66% of this sample, respectively. Among participants screening positive for insomnia and OSA, diagnosis codes for these disorders were present in the electronic medical record for 22 and 51%, respectively. Characteristics associated with insomnia were lower age (β (SE) = - 0.09 (0.04), 95% confidence interval [CI] = - 0.16, - 0.02), having a PTSD diagnosis (β (SE) = 1.68 (0.73), CI = 0.25, 3.11), greater pain severity (β (SE) = 0.36 (0.09), CI = 0.17, 0.55), and greater depressive symptoms (β (SE) = 0.84 (0.07), CI = 0.70, 0.98). Characteristics associated with OSA were higher BMI (odds ratio [OR] = 1.13, CI = 1.06, 1.21), greater depressive symptoms (OR = 1.12, CI = 1.05, 1.20), and opioid use (OR = 0.51, CI = 0.26, 0.99).Conclusions
Insomnia and OSA symptoms were very common in Veterans with OA, and a substantial proportion of individuals with symptoms may have been undiagnosed. Characteristics associated with insomnia and OSA symptoms were consistent with prior studies.Trial registration
NCT01130740 .Item Open Access The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight-loss maintenance.(Clin Trials, 2016-09-19) Shaw, Pamela A; Yancy, William S; Wesby, Lisa; Ulrich, Victoria; Troxel, Andrea B; Huffman, David; Foster, Gary D; Volpp, KevinBACKGROUND: Obesity continues to be a serious public health challenge. Rates are increasing worldwide, with nearly 70% of the US adults overweight or obese, leading to increased clinical and economic burden. While successful approaches for achieving weight loss have been identified, techniques for long-term maintenance of initial weight loss have largely been unsuccessful. Financial incentive interventions have been shown in several settings to be successful in motivating participants to adopt healthy behaviors. PURPOSE: Keep It Off is a three-arm randomized controlled trial that compares the efficacy of a lottery-based incentive, traditional direct payment incentive, and control of daily feedback without any incentive for weight-loss maintenance. This design allows comparison of a traditional direct payment incentive with one based on behavioral economic principles that consider the underlying psychology of decision-making. METHODS: Participants were randomized in a 2:1 ratio for each active arm relative to control, with a targeted 188 participants in total. Eligible participants were those aged 30-80 who lost at least 11 lb (5 kg) during the first 4 months of participation in Weight Watchers, a national weight-loss program, with whom we partnered. The interventions lasted 6 months (Phase I); participants were followed for an additional 6 months without intervention (Phase II). The primary outcome is weight change from baseline to the end of Phase I, with the change at the end of Phase II a key secondary endpoint. Keep It Off is a pragmatic trial that recruited, consented, enrolled, and followed patients electronically. Participants were provided a wireless weight scale that electronically transmitted daily self-monitored weights. Weights were verified every 3 months at a Weight Watchers center local to the participant and electronically transmitted. RESULTS: Using the study web-based platform, we integrated recruitment, enrollment, and follow-up procedures into a digital platform that required little staff effort to implement and manage. We randomized 191 participants in less than 1 year. We describe the design of Keep It Off and implementation of enrollment. LESSONS LEARNED: We demonstrated that our pragmatic design was successful in rapid accrual of participants in a trial of interventions to maintain weight loss. LIMITATIONS: Despite the nationwide reach of Weight Watchers, the generalizability of study findings may be limited by the characteristics of its members. The interventions under study are appropriate for settings where an entity, such as an employer or health insurance company, could offer them as a benefit. CONCLUSIONS: Keep It Off was implemented and conducted with minimal staff effort. This study has the potential to identify a practical and effective weight-loss maintenance strategy.Item Open Access The trials and tribulations of enrolling couples in a randomized, controlled trial: a self-management program for hyperlipidemia as a model.(Patient education and counseling, 2011-07) Voils, Corrine I; Yancy, William S; Weinberger, Morris; Bolton, Jamiyla; Coffman, Cynthia J; Jeffreys, Amy; Oddone, Eugene Z; Bosworth, Hayden BObjective
Capitalizing on spousal support may enhance the effectiveness of interventions for chronic disease management. However, couples-based interventions present logistical challenges. We describe our experience and lessons learned while recruiting couples into the Couples Partnering for Lipid-Enhancing Strategies (CouPLES) trial.Methods
This trial seeks to reduce serum low-density lipoprotein cholesterol levels using a couples-based intervention designed to help patients engage in self-management behaviors. We proposed enrolling 250 couples over 13 months.Results
Due to practical challenges that we encountered, recruitment and enrollment lasted 21 months. Those challenges included: travel to study site; effectively marketing the study; participant burden; and establishing eligibility criteria. By modifying our protocol to address these challenges, the recruitment rate increased from 12 to 33%.Conclusion
In the absence of trials identifying the most effective recruitment strategies, investigators may need to experiment, amending their protocol intermittently until target enrollment numbers are reached. The lessons we present may help researchers conducting couples-based interventions develop more effective protocols.Practice implications
To achieve target enrollment numbers, researchers conducting couples-based interventions should consider minimizing travel to the study site; carefully crafting recruitment materials; budgeting more for participant incentives and staff effort; and limiting exclusion criteria. These practices may also enhance retention.