Multiple sclerosis (MS) is a neurodegenerative disease characterized by a variable course and largely unpredictable exacerbations leading to progressive disability [1]. Within 15-20 years of disease onset, it is estimated that approximately 50% of people with MS will require a walking aid (eg, cane) to walk about 100 m with or without rest (ie, Expanded Disability Status Scale [2] score≥6) [3]. Approximately 40%-80% of people with MS with walking impairment report a need for support from informal care partners to engage in everyday activities and to participate in aspects of daily life that are important and meaningful to them [4-6]. Care partners are relatives, family members, or friends who provide a broad spectrum of assistance, ranging from help in activities of daily living to emotional support for people with MS [7]. Although there are positive aspects of MS caregiving [8], the negative effect on care partners’ own well-being is often great. MS care partners report poorer quality of life than the general population [9]. These MS care partners also experience a higher level of activity limitations, more emergency department visits, and hospitalizations than care partners of people with other chronic diseases [10]. Together, this evidence suggests that MS has life-altering consequences for people with MS and their care partners and points to an opportunity to identify strategies to improve the health of both partners to the benefit of each individual and the dyad (ie, partnership).

Physical activity (PA) is a health-promoting behavior in the general population and an emerging strategy for managing MS [11]. Researchers have reported that PA interventions that incorporate behavioral strategies (eg, goal setting) can increase PA levels and improve symptomatic and participatory outcomes among people with mild-to-moderate MS [12,13]. Emerging evidence from other chronic disease contexts (eg, dementia) suggests that dyadic behavioral PA interventions (ie, targeting both care recipients and care partners) can increase PA levels, improve physical and psychological health, and improve exercise adherence for both individuals [14,15]. Other researchers have reported a reduction in stress and improvement in coping skills among care partners of people with dementia after dyadic PA interventions [16,17]. Despite the promise of dyadic PA interventions, no studies to date have capitalized on the potential benefits of including both people with advanced MS and their care partners together as active participants in a dyadic behavioral PA intervention. We contend that a dyadic behavioral PA intervention could improve the well-being of people with MS and could help care partners maintain their roles for longer periods with lower health risks.

Within the literature specific to people with MS, there is limited research on behavioral PA interventions that can be widely disseminated for people with advanced MS who experience mobility and transportation limitations [18] and require high levels of caregiving support [19]. Dyadic health researchers have also been challenged to integrate telerehabilitation into intervention design to provide more sustainable and widely disseminated behavioral interventions for dyads with chronic health conditions [20]. Telephone delivery is one of the most widely available telerehabilitation modalities and holds distinct promise for its potential for adoption by public health systems and organizations (eg, MS Societies) that routinely provide telephone support for people with chronic health conditions [21,22]. In particular, group-based teleconferencing offers the added benefit of social modeling, social support, and opportunities for vicarious learning experiences [23,24]. Collectively, existing evidence suggests that telephone-based PA interventions have the potential to increase PA and improve the health of people with MS and their care partners.

The objective of this study is to conduct the first randomized controlled trial (RCT) to determine the feasibility of a dyadic behavioral PA intervention—Physical Activity Together for People With Multiple Sclerosis (PAT-MS) and their care partners. Specifically, we will explore the 4 primary areas of focus of feasibility studies (ie, process, resources, management, and scientific feasibility) [25,26] recommended for PA studies involving people with MS [27].

This protocol has been written following both the Standard Protocol Items: Recommendations for Interventional Trials and Consolidated Standards of Reporting Trials guidelines [28,29] (Multimedia Appendix 1). We will conduct a single site, assessor-blinded, parallel group, randomized controlled feasibility trial using a 1:1 allocation into an immediate intervention condition or a delayed intervention condition. A delayed intervention condition was deemed appropriate for PAT-MS based on the decision framework for appropriate control conditions for behavioral intervention trials [30,31].

Figure 1 presents the flow of participants throughout the study. All eligible participants will be scheduled for a baseline assessment (T1) for the provision of informed consent and collection of baseline data (scientific feasibility outcomes) at a university research laboratory. People with MS and their care partners will complete the measures in separate rooms to ensure privacy and confidentiality during the data collection process. Outcome measures will be collected by treatment-blinded assessors who are experienced with the administration of the proposed measures. In the 7 days following the baseline assessment, both people with MS and their care partners will be asked to wear an accelerometer during all waking hours. The accelerometer will be placed in a pouch on an elastic belt worn around the waist, with the device placed on the nondominant hip. Prestamped, preaddressed envelopes will be provided for the return of the accelerometer. Randomization will occur after baseline data collection.

The randomization sequence will be generated by an independent biostatistician using 1:1 permutated block randomization. Variable-sized blocks will be used to ensure approximately equal numbers in the 2 trial conditions. Participants will then complete the immediate intervention condition or the delayed intervention condition (ie, maintenance of usual activities) for 12 weeks. The same scientific feasibility outcomes as the baseline will be repeated immediately after the intervention (T2). We anticipate that each assessment session will last for approximately 2 hours. At the completion of the intervention, participants will also be asked to complete a satisfaction survey and an individual exit interview to assess their satisfaction with specific intervention components (ie, intervention content, interventionist, and delivery method) and their subjective experiences of participation in all aspects of PAT-MS, respectively. People with MS and their care partners will complete the same surveys. We anticipate that the survey will take approximately 15 minutes to complete. Individual exit interviews will be conducted over the phone by a member of the research team and will last for approximately 30 minutes. The same interview guide will be used for people with MS and their care partners. Participants in the delayed intervention condition will receive the intervention after the postintervention assessment (T2). We will follow the same intervention delivery procedures for the delayed condition as for the immediate intervention condition.

PAT-MS is a dyadic behavioral PA intervention approach that incorporates a toolbox of evidence-based strategies adapted from previous trials on promoting PA in care partners of people with Alzheimer disease [35,36], a comprehensive program of research [20,37-39], and input from people with MS and care partners. PAT-MS is grounded in the theory of dyadic illness management [40]. Behavior change techniques [41] that target key theoretical constructs from the social cognitive theory [42] and self-determination theory [43] are included to facilitate behavior change. The social cognitive theory and self-determination theory have proven effective for increasing PA in the general population [44] and among people with MS [45-47]. Table 1 provides a summary of the content and main behavior change techniques [41] that will be targeted across the six teleconference sessions. In brief, the intervention includes the following main components:

People with MS–care partner dyads will receive six group teleconferencing sessions (approximately 60 min each) every other week for a period of 12 weeks (Table 1). Each session is structured to include a review of material from the previous week, teaching content, group discussions, and explanation of practice activities to be completed before the next session. The group sessions will be interspersed with brief (approximately 15 min each) one-on-one support telephone calls in the weeks in which the group sessions do not occur. The intervention schedule will provide regular contact with the research team but will recognize the time commitment of the participants. We will seek to have 2-3 dyads on each teleconference call to manage the call more easily and to monitor the intervention process. The group-based teleconference format will provide opportunities for social modeling, social support, and vicarious learning experiences [23,24], which in turn will support behavior change, consistent with the theoretical foundations of PAT-MS [42,43]. Makeup sessions will be offered to those who miss teleconference sessions. The intervention will be delivered by a trained interventionist who will be provided with a structured manual for intervention delivery. Compliance to the protocol by the interventionist will be monitored using a checklist, weekly review meetings, and episodic monitoring of the teleconference sessions according to the guidelines of Bellg [49].

The outcomes will relate to process, resources, management, and scientific feasibility, as outlined below.

Progression to a pilot RCT will be considered if minimum success criteria are achieved in key feasibility metrics or if we can identify strategies for overcoming any identified challenges in these areas [70]. These criteria were selected based on the guidelines for prospectively defining progression to future evaluative studies [71,72]. The criteria include the following:

This protocol was approved by the Ottawa Hospital Research Ethics Board (20190329-01H) and the University of Ottawa Research Ethics Board (H-09-19-4886). The trial is conducted in compliance with the Declaration of Helsinki. Informed written consent will be obtained from all the participants.

Several direct outcomes are anticipated from this trial. First, the delivery of this trial will provide important insights for the research team on the practicality of running a future pilot trial, if the proposed intervention is feasible. Second, this trial will provide key information on the feasibility of PAT-MS, including estimates of recruitment, compliance, and attrition. It will also enable us to assess the acceptability of the intervention from the participants’ perspective. Finally, conducting this work will lead to the development of a manualized research protocol for PAT-MS. This manual will include the recruitment and selection criteria, details about the intervention and training of intervention staff, recommendations for managing study logistics, and possible challenges and strategies for overcoming them. The development of this manual will facilitate the delivery of future efficacy and effectiveness trials, including those using a multicenter approach. In addition, it will ensure the fidelity of the intervention and its long-term delivery in community, health care, or other multiservice settings.

The PAT-MS intervention is unique in several ways. PAT-MS uses a novel approach that combines both people with MS and their care partners together as active and collaborative participants in the intervention. There are potential synergistic benefits of this intervention on the health of each partner individually and on the dyad (ie, partnership). In addition, the focus on people with advanced MS disability is novel, as few interventions target this segment of the MS population. This MS cohort requires accessible strategies for disease management and requires high levels of caregiving support. Finally, the use of a telerehabilitation offers a cost-effective strategy for widespread long-term dissemination and is one of the preferred delivery formats for PA interventions among people with MS [73].

When executing the proposed trial, foreseeable challenges are compliance and attrition, which may be related to disease symptoms, comorbidities, or changes in medications. Care partners who are often working outside of the home, in addition to their caregiving role, may perceive participating in the intervention as a dyad to be burdensome, rather than beneficial. We have incorporated various methods into the study design to maximize retention and compliance: (1) flexibility in assessment sessions and phone call times; (2) follow-up by telephone and makeup session options; (3) offsetting participation costs through remuneration, toll-free calling, and reserved parking for testing visits; (4) including intervention content on the potential benefits of regular PA participation and how participants can safely engage in PA; and (5) incorporating behavior change techniques and using group-based delivery to reinforce social support, social modeling, and vicarious learning. Another potential challenge is the fidelity of the intervention. To promote the standard application of the intervention, an interventionist manual will be provided and incorporated into the interventionist’s training.

This is the first study to examine the feasibility of the PAT-MS intervention. PAT-MS offers people with MS who have advanced disability and their care partners an opportunity to achieve important health and well-being benefits associated with PA participation. The findings from this study will be relevant in informing future dyadic health promotion research in MS.