Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams

Background: Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial. Methods: Four-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants-patients of an interprofessional primary care team-were over age 18 years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: Uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes. Results: Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers (n = 20) met 28 clients in 234 client encounters (home visits, phone calls, electronic messages); 27 reports were sent to the interprofessional team. At 4 months, controlling for baseline, most outcomes were better in the intervention compared to control group; physical activity notably better. The most common goal domains set were physical activity, diet/nutrition, and social connection. Clients felt the biggest impact was motivation toward goal achievement. They struggled with some of the technologies. Several participants perceived that the program was not a good fit, mostly those that felt they were already well-managing their diabetes. Conclusions: Health TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others. Trial registration: ClinicalTrials.gov, NCT02715791. Registered 22 March 2016-retrospectively registered

A protocol for a pragmatic randomized controlled trial using the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) platform approach to promote person-focused primary healthcare for older adults

Detailed description of the intervention [57, 84–89]. (DOC 63 kb

Cyk-4: A Rho Family Gtpase Activating Protein (Gap) Required for Central Spindle Formation and Cytokinesis

During cytokinesis of animal cells, the mitotic spindle plays at least two roles. Initially, the spindle positions the contractile ring. Subsequently, the central spindle, which is composed of microtubule bundles that form during anaphase, promotes a late step in cytokinesis. How the central spindle assembles and functions in cytokinesis is poorly understood. The cyk-4 gene has been identified by genetic analysis in Caenorhabditis elegans. Embryos from cyk-4(t1689ts) mutant hermaphrodites initiate, but fail to complete, cytokinesis. These embryos also fail to assemble the central spindle. We show that the cyk-4 gene encodes a GTPase activating protein (GAP) for Rho family GTPases. CYK-4 activates GTP hydrolysis by RhoA, Rac1, and Cdc42 in vitro. RNA-mediated interference of RhoA, Rac1, and Cdc42 indicates that only RhoA is essential for cytokinesis and, thus, RhoA is the likely target of CYK-4 GAP activity for cytokinesis. CYK-4 and a CYK-4:GFP fusion protein localize to the central spindle and persist at cell division remnants. CYK-4 localization is dependent on the kinesin-like protein ZEN-4/CeMKLP1 and vice versa. These data suggest that CYK-4 and ZEN-4/CeMKLP1 cooperate in central spindle assembly. Central spindle localization of CYK-4 could accelerate GTP hydrolysis by RhoA, thereby allowing contractile ring disassembly and completion of cytokinesis

Plasmid-Cured Chlamydia caviae Activates TLR2-Dependent Signaling and Retains Virulence in the Guinea Pig Model of Genital Tract Infection

Loss of the conserved “cryptic” plasmid from C. trachomatis and C. muridarum is pleiotropic, resulting in reduced innate inflammatory activation via TLR2, glycogen accumulation and infectivity. The more genetically distant C. caviae GPIC is a natural pathogen of guinea pigs and induces upper genital tract pathology when inoculated intravaginally, modeling human disease. To examine the contribution of pCpGP1 to C. caviae pathogenesis, a cured derivative of GPIC, strain CC13, was derived and evaluated in vitro and in vivo. Transcriptional profiling of CC13 revealed only partial conservation of previously identified plasmid-responsive chromosomal loci (PRCL) in C. caviae. However, 2-deoxyglucose (2DG) treatment of GPIC and CC13 resulted in reduced transcription of all identified PRCL, including glgA, indicating the presence of a plasmid-independent glucose response in this species. In contrast to plasmid-cured C. muridarum and C. trachomatis, plasmid-cured C. caviae strain CC13 signaled via TLR2 in vitro and elicited cytokine production in vivo similar to wild-type C. caviae. Furthermore, inflammatory pathology induced by infection of guinea pigs with CC13 was similar to that induced by GPIC, although we observed more rapid resolution of CC13 infection in estrogen-treated guinea pigs. These data indicate that either the plasmid is not involved in expression or regulation of virulence in C. caviae or that redundant effectors prevent these phenotypic changes from being observed in C. caviae plasmid-cured strains

Responding to and Recovering from a Body-related Threat: An Application of Social Self-Preservation Theory

Social self-preservation theory (SSPT) suggests that when faced with social-evaluative threat, a set of psychological and physiological responses are elicited concurrently (Dickerson, Gruenewald, & Kemeny, 2004; Kemeny, Gruenewald, & Dickerson, 2004). A series of studies examined the applicability of SSPT to the examination of social-evaluative body-related threats. In the first study, interviews were conducted to identify and describe uncomfortable body-related situations, and typical responses to such situations. Findings provided preliminary evidence of the applicability of SSPT to everyday body-related threats of young adult women – the threats, context of those threats, and responses to such threats were consistent with SSPT. The second study examined psychobiological responses to, and recovery from, a social-evaluative body-related threat. Findings from this study showed that the social-evaluative body-related threat elicited a psychobiological response consistent with SSPT; women in the threat group reported higher social physique anxiety and had higher cortisol following the threat. The third study sought to extend the applicability of SSPT to examine the psychobiological responses to, and recovery from, an anticipated social-evaluative body-related threat. In addition, the potential moderating effect of appearance investment on responses to a threat was examined. Findings from this study showed that women in the threat group reported higher shame and social physique anxiety after anticipating a social-evaluative body-related threat than following a quiet rest period for women in the control group. Results also indicated that both groups showed an index of decrease for cortisol, with the control group showing a significantly greater overall decrease than the threat group. Appearance investment did not moderate cortisol responses to a threat. Findings from the third study provide partial support for SSPT’s applicability to the anticipation of a social-evaluative body-related threat. Together findings from all three studies provide converging evidence for the use of SSPT in understanding the psychobiology of body image.Ph

The exercise leader's gender and physique salience : effects on self-presentational concerns in an exercise context

Self-presentation is the process by which individuals attempt to monitor and control how others perceive and evaluate them (Leary, 1992; Leary & Kowalski, 1990). Self-presentational concerns have been shown to influence a number of exercise-related behaviours, cognitions, and affective responses to exercise (e.g., social anxiety). Social anxiety occurs when an individual wants to create a specific impression on others, but is unsure (s)he will be successful (Leary & Kowalski, 1995). Social physique anxiety (SPA) is a specific form of social anxiety related the evaluation of one's body (Hart, Leary, & Rejeski, 1989). Both social anxiety and SPA may act as deterrents to exercise (Lantz, Hardy, & Ainsworth, 1997; Leary, 1992), so it is important to examine factors that may influence social anxiety and SPA; one such factor is self-presentational efficacy (SPE). SPE is one's confidence in successfully making desired impressions on others (Leary & Atherton, 1986) and has been associated with social anxiety and SPA (Leary & Kowalski, 1995; Gammage, Martin Ginis, & Hall, 2004). Several aspects of the exercise environment, such as the presence of mirrors, clothing, and the exercise leader or other participant characteristics, may be manipulated to influence self-presentational concerns (e.g., Gammage, Martin Ginis et aI., 2004; Martin & Fox, 2001; Martin Ginis, Prapavessis, & Haase, 2005). Given that the exercise leader has been recognized as one of the most important influences in the group exercise context (Franklin, 1988), it is important to further examine how the leader may impact self-presentational concerns. The present study examined the impact of the exercise leader's gender and physique salience (i.e., the extent to which the body was emphasized) on SPE, state social anxiety (SSA), and state social physique anxiety (SPA-S) of women in a live exercise class. Eighty-seven college-aged female non- or infrequent exercisers (i.e., exercised 2 or fewer times per week) participated in a group exercise class led by one of four leaders: a female whose physique was salient; a female whose physique was non-salient; a male whose physique was salient; or a male whose physique was non-salient. Participants completed measures of SPE, SSA, and SPA-S prior to and following completion of a 30- minute group exercise class. In addition, a measure of social comparison to the exercise leader and other participants with respect to attractiveness, skill, and fitness was completed by participants following the exercise class. A MANOV A was conducted to examine differences between groups on postexercise variables. Results indicated that there were no significant differences between groups on measures ofSPE, SSA, or SPA-S (allp's > .05). However, when all participants were collapsed into one group, a MANOV A showed a significant time effect (F(3, 81) = 19.45,p < .05, 1')2= .419). Follow-up ANOVAs indicated that post-exercise SPE increased significantly, while SSA and SPA-S decreased significantly (SPE: F(I, 83) = 30.87,p < .001,1')2 = .27; SSA: F(I,83) = 11.09,p < .001, 1')2 = .12; SPA-S: F (1,83) = 42.79,p < .001, 1')2 = .34). Further, results of a MANOVA revealed that participants who believed they were less fit than other group members (i.e., made negative social comparisons) reported significantly more post-exercise SSA and SP A-S than those who believed they were more fit than the other participants (i.e., made positive comparisons; SSA: F(2, 84) = 3.46, p < .05, 1')2 = .08; SPA-S: F(2, 84) = 5.69, p < .05, 1')2 = .12). These results may indicate that successfully completing an exercise class may serve as a source of SPE and lead to reduced social anxiety and SPA-S in this population. Alternatively, characteristics of the exercise leader may be less important than characteristics of the other participants. These results also suggest that the types of social comparisons made may influence self-presentational concerns in this sample. Future research should examine how the type of social comparison (i.e., negative or positive) made to the other group members may either generate or reduce anxiety. Also, factors that contribute to the types of social comparisons made with other exercisers should be examined. Implications for practice and research are discussed

Psychological and Cortisol Responses to and Recovery From Exposure to a Body Image Threat

The majority of body image research has failed to measure what occurs beyond the immediate presentation of a body image threat, or after a body image threat is no longer present. This is particularly true for physiological outcomes. The present study examined psychological and cortisol responses to, and recovery from, a body composition assessment as a social-evaluative body image threat. Women (N = 64) were randomized into either a control or threat group. Participants completed a measure of social physique anxiety and provided a sample of saliva (to assess cortisol) at baseline, and immediately following and 20 min following their condition. The threat group reported higher social physique anxiety following the threat in comparison with both baseline levels and recovery levels. Cortisol was higher immediately following the threat in comparison with baseline levels. Findings support the inclusion of a recovery time point in body image research to provide a more complete picture of the psychobiology of body image experiences

A Volunteer Program to Connect Primary Care and the Home to Support the Health of Older Adults: A Community Case Study

Primary care providers are critical in providing and optimizing health care to an aging population. This paper describes the volunteer component of a program (Health TAPESTRY) which aims to encourage the delivery of effective primary health care in novel and proactive ways. As part of the program, volunteers visited older adults in their homes and entered information regarding health risks, needs, and goals into an electronic application on a tablet computer. A total of 657 home visits were conducted by 98 volunteers, with 22.45% of volunteers completing at least 20 home visits over the course of the program. Information was summarized in a report and electronically sent to the health care team via clients’ electronic medical records. The report was reviewed by the interprofessional team who then plan ongoing care. Volunteer recruitment, screening, training, retention, and roles are described. This paper highlights the potential role of a volunteer in a unique connection between primary care providers and older adult patients in their homes

Feasibility study of goal setting discussions between older adults and volunteers facilitated by an eHealth application: development of the Health TAPESTRY approach

Abstract Background In keeping with the changing needs of the Canadian population, primary care systems need to become more person-focused in providing quality care to older adults. As part of Health TAPESTRY, a complex intervention to strengthen primary care for older adults, a goal setting exercise was developed and tested in an initial feasibility study, intended to foster collaboration between patients and providers. Methods Participants—clinic clients—were recruited from the McMaster Family Health Team in Hamilton, Ontario. Five participants took part in the goal setting feasibility study phase I, which tested the functionality of a technology-enabled goal setting exercise between older adults and volunteers. Based on observations and feedback from volunteers, interprofessional team members, and older adults, the exercise was refined to include a guided survey and goals report. The goal setting survey is a list of probing questions designed based on SMART (specific, measurable, attainable, relevant, timely) goal setting strategies and goal attainment scaling (GAS). This was used in phase II, carried out with 16 participants, where the feasibility of goal setting and goal attainment with support from volunteers and interprofessional teams was tested. Volunteers carried out the goal setting survey via a tablet computer, a report of client goals was generated and sent to interprofessional teams, and client goals were discussed during clinic huddles. At 6 months of follow-up, clients self-evaluated their progress using GAS. Results and discussion The goal setting exercise in phase I took an average of 24:45 (SD 11:42) minutes and yielded a diverse set of life and health goals. Goals identified by older adults were primarily focused on the maintenance of a certain level of activity or health state. Phase I work resulted in important changes to the goal setting process (e.g., asking about goal setting later in conversation, changing wording of questions) and development of a summary report of goals sent to the interprofessional team. In phase II, 44 goals were set by 16 participants during an average 7:23 (SD 4:26) minute discussion. Of these goals, 43.9% were characterized as health goals while 63.4% were characterized as life goals. Under the umbrella of Life goals, productivity featured most prominently at 22.9% of all goals. Goal attainment was not measured in phase I. In phase II, clients had an average weighted goal attainment score of 51.5. Considering client preferences for one goal over another, 68.8% of clients, on average, at least partially achieved the goals they had set. Conclusion Goal setting as part of the Health TAPESTRY approach was feasible and provided interprofessional teams with client narratives that helped improve care management for older adults. The overall intervention—including the refined goal setting component—is being scaled and evaluated in a pragmatic randomized controlled trial

Protocol for a Delphi consensus exercise to identify a core set of criteria for selecting health related outcome measures (HROM) to be used in primary health care

Abstract Background Promoting the collection and use of health related outcome measures (HROM) in daily practice has long been a goal for improving and assessing the effectiveness of care provided to patients. However, there has been a lack of consensus on what criteria to use to select outcomes or instruments, particularly in the context of primary health care settings where patients present with multiple concurrent health conditions and interventions are whole-health and person-focused. The purpose of this proposed study is to undertake a formal consensus exercise to establish criteria for selecting HROM (including patient-reported (PRO or PROM), observer-reported (ObsR)), clinician-reported (ClinRO) and performance related outcomes (PerfO) for use in shared decision-making, or in assessing, screening or monitoring health status in primary health care settings. Methods A Delphi consensus online survey will be developed. Criteria for the Delphi panel participants to consider were selected from a targeted literature search. These initial criteria (n = 35) were grouped into four categories within which items will be presented in the Delphi survey, with the option to suggest additional items. Panel members invited to participate will include primary health care practitioners and administrators, policy-makers, researchers, and experts in HROM development; patients will be excluded. Standard Delphi methodology will be employed with an expectation of at least 3 rounds to achieve consensus (75% agreement). As the final list of criteria for selecting HROM emerges, panel members will be asked to provide opinions about potential weighting of items. The Delphi survey was approved by the Ethics Committee in the Faculty of Health Sciences at McMaster University. Discussion Previous literature establishing criteria for selecting HROM were developed with a focus on patient reported outcomes, psychological/ behavioural outcomes or outcomes for minimum core outcome sets in clinical trials. Although helpful, these criteria may not be applicable and feasible for application in a primary health care context where patients with multi-morbidity and complex interventions are typical and the constraints of providing health services differ from those in research studies. The findings from this Delphi consensus study will address a gap for establishing consensus on criteria for selecting HROM for use across primary health care settings