Agarwal Gina, Gaber Jessica, Richardson Julie, Mangin Dee, Ploeg Jenny, Valaitis Ruta, Reid Graham J, Lamarche Larkin, Parascandalo Fiona, Javadi Dena, O'Reilly Daria, Dolovich Lisa
1Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 5th Floor, 1280 Main Street West, Hamilton, Ontario L8S 4K1 Canada.
2School of Rehabilitation Science, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1 Canada.
Pilot Feasibility Stud. 2019 Oct 27;5:118. doi: 10.1186/s40814-019-0504-8. eCollection 2019.
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.
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.
Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers ( = 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.
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.
ClinicalTrials.gov, NCT02715791. Registered 22 March 2016-retrospectively registered.
大多数糖尿病患者的医疗护理是在家庭医疗中进行的，然而，平衡帮助这些患者所需的时间和资源可能很困难。一种能够增强患者能力、利用社区资源并协助自我管理的干预措施可能会使患者和医疗服务提供者受益。因此，探讨了“通过糖尿病管理健康连接器推进患者体验、加强质量的健康团队”（Health TAPESTRY-HC-DM）作为支持糖尿病自我管理方法的可行性和有效性潜力，以为未来大规模试验的开展提供信息。
为期四个月的试点随机对照试验（RCT），采用序贯解释性定性成分。参与者为一个跨专业初级保健团队的患者，年龄在18岁以上，被诊断患有糖尿病和高血压，能够上网，且符合以下条件之一：糖化血红蛋白（HbA1c）控制不佳、近期诊断为糖尿病、终末期/继发性器官损伤或经医疗服务提供者转诊。Health TAPESTRY-HC-DM干预措施侧重于患者的健康目标/需求，整合社区志愿者、电子健康技术、跨专业初级保健团队和系统导航。试点结果包括过程指标（招募、留存、项目参与情况）、对项目可行性的认知、益处和改进领域，以及风险或安全问题。主要试验结果是糖尿病管理的自我效能感。还有一些次要试验结果。
在425名被邀请的符合条件的患者中，50人签署了同意书（11.8%），35人完成了该项目（15人干预组，20人对照组）。志愿者（n = 20）在234次与客户的接触（家访、电话、电子信息）中会见了28名客户；向跨专业团队发送了27份报告。在4个月时，在控制基线的情况下，与对照组相比，干预组的大多数结果更好；身体活动方面明显更好。设定的最常见目标领域是身体活动、饮食/营养和社交联系。客户认为最大的影响是对实现目标的激励。他们在一些技术方面遇到了困难。一些参与者认为该项目不太适合，主要是那些觉得自己已经很好地管理糖尿病的人。
Health TAPESTRY-HC-DM是可行的；大规模随机对照试验似乎是可能的。然而，需要进一步关注改善招募和留存情况。该干预措施受到了好评，不过对一些参与者比对另一些参与者更合适。
ClinicalTrials.gov，NCT02715791。2016年3月22日注册——追溯注册。
