Evaluating the Efficacy of the "Support for Life" Program for People with Dementia and Their Families and Carers' to Enable Them to Live Well: A Protocol for a Cluster Stepped Wedge Randomized Controlled Trial

Abstract

Introduction: Assistance provided to support people living with dementia and carers is highly valued by them. However, current support systems in Australia are disjointed, inaccessible to all, poorly coordinated, and focus on dysfunction rather than ability. Support workers for people with dementia are in short supply, and there is little consistency in their roles. To address this large service gap and unmet need, we have developed an evidence-based optimized model of holistic support for people with dementia and their carers and families. This article describes the "Support for Life" model intervention.

Methods: A stepped wedge cluster randomized controlled trial will be conducted over 3 years across three Australian states. One hundred participants with dementia and/or their carers/family members will be randomly selected from community health center client lists in each state to receive either the dementia "Support for Life" intervention (Group A) or routine care (Group B). Group A participants will have access to the intervention from year 1. Group B participants will continue to receive usual care and will not be denied information on dementia or dementia services in year 1. In year 2, Group B participants will have access to the intervention. A highly trained expert dementia support worker will provide the "Support for Life" intervention, which is a flexible, individually tailored, holistic support that is relationship-centered, focused on enablement as opposed to dysfunction, and facilitate participants' continued engagement in their community and the workforce. Additionally, dementia education, information resources, advocacy, and practical support to navigate and access dementia services and health care will be provided. The mode of support will include face to face, telephone, and internet interaction on an "as needed basis" for 12 months. The primary hypothesis is that the intervention will improve the quality of life of people with dementia and the health and well-being of carers/family through facilitating the continuation and enhancement of regular daily activities. Secondary hypotheses will examine other health and service usage outcomes. The outputs will also include a health economic analysis to investigate the costs (and savings) of any associated reduction in unnecessary health services use and delay in accessing permanent residential aged care.

Trial registration number: Australian and New Zealand Clinical Trials Registry: ACTRN12616000927426p.

Keywords: RCT; carer support; dementia; protocol; quality of life; well-being.

Figures

Figure 1

“Support for Life” stepped wedge cluster randomized control trial (SWcRCT) study design. Overall, there are 30 clusters participating, 10 clusters in each state, and so the above figure shows the design that is replicated in each state. In each cluster, we aim to recruit 10 study participants having dementia or cognitive impairment, making the overall recruitment target at 300 participants. Data are collected from all participants during the seven data collection time points shown by a dashed-line in the above figure (i.e., at baseline and 3, 6, 12, 15, 18, and 24 months). We expect an attrition rate of 20 percent; therefore, we expect approximately 240 participants with dementia or cognitive impairment and approximately 1,680 participant data points to be examined in this SWcRCT. Attrition is expected to occur at any time point, and the modeling will include all participant data; participant data may be complete (available from all seven time points) or incomplete (available from one to six time points). The intensive intervention phase is shown in dark blue. The post-intervention phase is shown in light-blue (this is the second year for the year 1 intervention group), where participants can still access the intervention, but the intervention will no longer be promoted at those clusters.