ACHRU Community Partnership Program for Diabetes Self-Management for Older Adults - Canada
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 295
- 试验地点
- 4
- 主要终点
- Mental Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Mental Component Summary score.
研究概览
简要总结
Living with diabetes and other chronic (ongoing) conditions is common in older adults. These individuals have poorer health and higher use of health services compared to older adults with diabetes alone. Programs that help older adults self-manage their diabetes and other health conditions benefit both individuals and the healthcare system. The McMaster University Aging, Community and Health Research Unit developed and tested a new patient-centered, community-based program (CPP) to improve the delivery and outcomes of care for older adults with diabetes and other chronic conditions. This 6-month program was developed in partnership with patients, caregivers, primary and community care providers and researchers. The program is delivered by nurses, dietitians and community providers. It involves in-home or virtual visits by nurses and dietitians, monthly group wellness sessions at community centers or virtually, and monthly virtual team meetings. Wellness sessions include exercise, education, and social support. Caregivers are invited to be active participants along with patients. The program was successfully implemented in Ontario and Alberta. Participants who received the program had better quality of life, self-management, and mental health at no additional cost from a societal perspective compared to those receiving usual care. To determine how the program can best help people, more testing is needed with different communities and groups of people. We will partner with primary healthcare teams (e.g., family doctors' offices) in three provinces to adapt and test the program in a variety of real-world settings. We will assess how to best put this program into practice and measure outcomes important to patients and caregivers so study results are relevant to them. Study findings will guide the development of a plan for expanding the program to reach and benefit more older adults with diabetes and other chronic health conditions. Patients and caregivers will be involved as key partners in all aspects of the research.
详细描述
The purpose of this study is to examine the implementation and effectiveness of the CPP intervention in new settings and populations to demonstrate widespread effectiveness and ways to adapt CPP for diverse population subgroups and primary care setting and community care contexts. Based on the investigator's previous work, we expect that the CPP intervention will result in a greater improvement in mental health and will be cost neutral relative to usual care because program costs will be offset by lower use of other health services. A cross-jurisdictional, multi-site implementation-effectiveness type II hybrid randomized controlled trial will be conducted. The trial will be conducted in two sites in each of Ontario, Quebec, and Prince Edward Island. Each of the six sites will involve a primary care setting and a community care organization. Study participants will be randomly assigned to the intervention or usual care group. Participants randomly assigned to the intervention group will be offered the 6-month CPP intervention in addition to their usual primary care services offered by their local diabetes education centre or primary care setting. The primary outcome of intervention effectiveness is patient mental health. Other health outcomes for patients and their caregivers will be assessed (e.g., depression, anxiety, use of health and social services etc.). Implementation will be examined in-detail through qualitative evaluations with providers, patients and caregivers. Engagement of patients and caregivers will occur in all stages of the research study. Qualitative evaluation of patients and caregivers as research partners will be conducted through annual evaluations. Patient, Public (e.g., caregivers, knowledge users) and Community (e.g., local providers/representatives) Research Partners will be engaged in the research study by way of the study's established governance structures: Community Advisory Boards, Patient Advisory Council, and Steering Committee. Qualitative evaluation of Patient, Public and Community Research Partners will be conducted to inform implementation of the CPP intervention at the local context and the potential for widespread implementation and scale-up. Both quantitative and qualitative evaluations will be used to interpret study findings, and in the development of scale-up plans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient participants ("CPP Target Population") will be included in the study if they meet the following inclusion criteria:
- •Diagnosis of type 1 or type 2 diabetes
- •Aged 65+ years
- •Enrolled in a primary care organization
- •Diagnosed with at least one other chronic condition
- •Residing in the area served by the primary care and community site
- •Capable of providing informed consent, or has a substitute decision-maker who is able to provide informed consent on his/her behalf
- •Competent in English or has an interpreter who is competent in English for Ontario and Prince Edward Island (PEI) study sites. Patient participants that score 5 or higher on The Short Portable Mental Status Questionnaire (SPMSQ) will be eligible as patient participants. Those with scores below 5 will be eligible if they have a proxy decision-maker.
- •Caregiver participants will be included in the study if they meet the following inclusion criteria:
- •Identified by the patient participant as an informal family or friend caregiver
- •At least 18 years of age
- •Provides physical, emotional, or financial care to the patient participant
- •Scores 5 or higher on the SPMSQ
- •Provider and manager participants will be included in the study if they meet the following inclusion criteria:
- •Working with the primary care setting or community partner organization at a study site
- •Either a Registered Nurse (RNs) or Registered Dietitian (RDs) at the primary care setting
- •A Program Coordinator (PC) from the community partner organization
- •A manager of the RN or RD at the primary care setting
- •A manager of the PC at the community partner organization
- •Patient, Public and Community Research Partner participants will be included in the study if they meet the following inclusion criteria:
- •Older adult living in the community, or
- •Community living family or friend caregiver of a person with a diagnosis of diabetes and one or more chronic condition, or
- •Community living health provider or manager of persons with diabetes and one or more chronic condition, or
- •A knowledge user (e.g. policy maker) who works in health planning or health policy decision making at the community level representative of study sites
- •Persons not receiving the CPP intervention
排除标准
- •Patient and caregiver participants in Ontario and PEI who do not speak English and do not have an interpreter/translator
结局指标
主要结局
Mental Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Mental Component Summary score.
时间窗: Baseline, 6-months
The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess mental health. The tool consists of 12 questions that measure functional health and well-being from the participant's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, mental health), by which a psychometrically-based Physical Component Summary (PCS) and Mental Component Summary (MCS) can be calculated. Response options include the frequency of feeling a certain way or behaviour across 3 or 5 categories (e.g., 'all of the time'...'none of the time'). Patients and caregivers will be evaluated for change in SF-12-MCS from baseline to 6-months. Total scale range: 0 - 100. Higher scores represent better mental functioning.
次要结局
- Self-Management Using the Summary of Diabetes Self-Care Activities (SDSCA)(Baseline, 6-months)
- Physical Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Physical Component Summary score.(Baseline, 6-months)
- Depressive Symptoms Using the Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10)(Baseline, 6-months)
- Level of Anxiety Using the Generalized Anxiety Disorder 7-Item (GAD-7)(Baseline, 6-months)
- Physical Activity Using the Physical Activity Scale for the Elderly (PASE)(Baseline, 6-months)
- Caregiver Strain Using the Modified Caregiver Strain Index (MCSI)(Baseline, 6-months)
- Social Support Using the Abbreviated Duke Social Support Index (DSSI)(Baseline, 6-months)
- Functional Status Using the Duke Older Americans Resources and Services Procedures (OARS) Multidimensional Functional Assessment Questionnaire - Activities of Daily Living section(Baseline, 6-months)
- Nutritional Status Using the Seniors in the Community Risk Evaluation for Eating and Nutrition tool (SCREEN II-AB)(Baseline, 6-months)
- Shared Decision-Making Using the CollaboRATE tool(Baseline, 6-months)
- Service Use Using the Health and Social Services Utilization Inventory (HSSUI)(Baseline, 6-months)
- Glycated hemoglobin (HbA1c)(Baseline, 6-months)
- Glomerular Filtration Rate (GFR)(Baseline, 6-months)
- Low-Density Lipoprotein (LDL)(Baseline, 6-months)
- Collaboration Using the Partnership Self-Assessment Tool (PSAT)(6-months)
研究者
Maureen Markle-Reid
Professor
McMaster University