Study protocol: pragmatic randomized control trial of an internet-based intervention (My tools 4 care) for family carers

Wendy Duggleby, Jenny Ploeg, Carrie McAiney, Kathryn Fisher, Jenny Swindle, Tracey Chambers, Sunita Ghosh, Shelley Peacock, Maureen Markle-Reid, Jean Triscott, Allison Williams, Dorothy Forbes, Lori Pollard, Wendy Duggleby, Jenny Ploeg, Carrie McAiney, Kathryn Fisher, Jenny Swindle, Tracey Chambers, Sunita Ghosh, Shelley Peacock, Maureen Markle-Reid, Jean Triscott, Allison Williams, Dorothy Forbes, Lori Pollard

Abstract

Background: Family carers of older persons with Alzheimer's' disease and related dementia (ADRD) and multiple chronic conditions (MCC) experience significant, complex, and distressing transitions such as changes to their environment, roles and relationships, physical health, and mental health. An online intervention (My Tools 4 Care) was developed for family carers of persons with ADRD and MCC living at home, with the aim of supporting these carers through transitions and increasing their self-efficacy, hope, and health related quality of life (HRQoL). This study will evaluate My Tools 4 Care (MT4C) by asking the following research questions: 1. Does use of MT4C result in a 3 month (immediately post intervention) and 6-month (3 months after intervention) increase in HRQoL, self-efficacy, and hope, in carers of persons with ADRD and MCC compared to an educational control group? 2. Does use of MT4C help carers of community-dwelling older adults with ADRD and MCC deal with significant changes they experience as carers? and 3. Are the effects/benefits of the MT4C intervention achieved at no additional cost compared to an educational control group?

Methods/design: Using a pragmatic mixed methods randomized controlled trial design, 180 family carers of community dwelling older persons (65 years of age and older) with ADRD and MCC will participate in the study. Data will be collected from the intervention and an educational control group at four time points: baseline, 1 month, 3 and 6 months. We expect to find that family carers using MT4C will show greater improvement in hope, self-efficacy and HRQoL, at no additional cost from a societal perspective, compared to those in the educational control group. General estimating equations will be used to determine differences between groups and over time.

Discussion: Data collection began in Ontario and Alberta Canada in June 2015 and is expected to be completed in June 2017. The results will inform policy and practice as MT4C can be easily revised for local contexts and is scalable in terms of posting on websites such as those hosted by the Alzheimer Society.

Trial registration: ClinicalTrials.gov Identifier: NCT02428387.

Keywords: Carers; Dementia; Online intervention; Pragmatic Trial.

Conflict of interest statement

Ethics approval and consent to participate

This study received ethical approval from the University of Alberta Health Research Ethics Board (# Pro00048721) and the Hamilton Integrated Research Ethics Board in Hamilton, Ontario (#15–309). All study participants will be asked for telephone consent. Furthermore the study has been registered under the NIH trials registry.

Consent for publication

This manuscript does not contain any individual data so consent for publication is not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study protocol MT4C
Fig. 2
Fig. 2
Conceptual framework for MT4C

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