Comparing a Multiple Sclerosis Fatigue Management Course Delivered via Teleconference, Internet, or in Person

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In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.

What was this COVID-19 study about?

Multiple sclerosis, or MS, is a health problem that affects the central nervous system. It disrupts the flow of information between the brain and the rest of the body. MS affects people differently. It can cause problems with vision, balance, muscle control, and daily activities.

Unpaid caregivers, such as family or friends, can give physical and emotional support to people with MS. During the pandemic, caregivers had to deal with new challenges, like protecting themselves and those they care for from COVID-19. But they often had limited support or information. Many caregivers reported having mental health issues, such as stress or anxiety.

In this study, the research team compared two programs to improve mental health for caregivers of people with MS:

• Website alone. Caregivers received a link to a website that had educational content, links to resources, and four short videos. Topics included finding helpful information about MS on the web, caring for someone with MS and for themselves, and preventing the spread of COVID-19.
• Website with coaching. Caregivers received a link to the website. They also received virtual coaching, which included four video or phone calls with a social worker. Sessions covered caregivers’ needs for information and support. They also covered ways of caring for family members with MS, caring for themselves, and planning for the future.

What were the results?

After three months, compared with caregivers who received the website alone, caregivers who also received coaching had:

• Less stress and negative emotions
• Similar levels of depression and anxiety related to COVID-19

Who was in the study?

The study included 151 caregivers of people with MS. Of these, 86 percent were White, and 14 percent were African American, Asian, Hispanic, or another race or ethnicity. The average age was 53, and 53 percent were women. People in the study lived across the United States.

What did the research team do?

The research team assigned caregivers by chance to receive the website alone or the website with coaching. The programs lasted six weeks.

Caregivers completed surveys at the start of the study and three months later. The surveys asked about stress, emotional state, depression, and anxiety related to COVID-19.

Caregivers, people with MS, doctors, and health insurers gave input on the study.

What were the limits of the study?

Caregivers who took part in the study may have differed from caregivers who didn’t take part. For example, they may have been more motivated to reduce stress. The study looked at mental health outcomes after three months; the research team wasn’t able to learn if improvements in stress and emotional state lasted beyond three months.

How can people use the results?

Health organizations can use the results when considering how to support caregivers of people with MS.

In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.

Background

The COVID-19 pandemic has disproportionately burdened caregivers of people with chronic illnesses, such as multiple sclerosis (MS). MS is an illness that affects the central nervous system. It can cause problems with vision, balance, muscle control, and other basic body functions. Unpaid caregivers, such as family or friends, can provide physical and emotional support for patients. The COVID-19 pandemic posed new challenges for caregivers and, for many, affected their mental health.

Objective

To compare the effectiveness of two interventions in reducing stress, negative emotional state, depression, and COVID-19-related anxiety for caregivers of people with MS

Study Design

This randomized controlled pilot trial compared the effectiveness of an educational website with and without tele-coaching on reducing stress, negative emotional state, depression, and COVID-19-related anxiety for caregivers of people with MS.

Researchers randomly assigned caregivers to receive the educational website with tele-coaching or the educational website alone. The website consisted of educational content, links to resources, and four short videos. The videos included information on obtaining reliable information about MS on the web, caring for someone with MS, dealing with COVID-19 and MS, MS self-care, and planning and decision making. Tele-coaching consisted of four one-on-one videoconference or phone sessions with a social worker. In the tele-coaching sessions, the social worker and caregiver discussed caregivers’ needs for information and support, strategies for caring for family members with MS, caregiver self-care, and planning for the future. The interventions lasted six weeks.

The study included 151 unpaid caregivers of people with MS. Caregivers lived across the United States and received access to the interventions virtually. Among caregivers, 86% were non-Hispanic White and 14% were Hispanic, African American, Asian, or another race or ethnicity. The average age was 53, and 53% were female.

At baseline and again 12 weeks later, caregivers completed web-based surveys on demographic information and stress, overall negative emotional state, depression, and COVID-19-related anxiety.

Caregivers, people with MS, health insurers, and clinicians provided input throughout the study.

Results

After 12 weeks, compared with caregivers who received the website alone, caregivers who also received tele-coaching reported a greater decrease in stress (p=0.047) and negative emotional state (p=0.037). Improvements in depression symptoms or COVID-19-related anxiety did not differ significantly between caregivers who received the website with or without tele-coaching.

Limitations

Caregivers who participated were motivated to take part in the study, which may have contributed to selection bias. Because the study lacked long-term follow-up, researchers were unable to determine if caregivers had sustained improvements in stress and negative emotional state.

Conclusions and Relevance

In this study, compared with the educational website alone, the website with tele-coaching was more effective in reducing stress and overall negative emotional state but not depression or COVID-19-related anxiety for caregivers of people with MS. Results may help healthcare organizations when considering ways to support caregivers of people with MS.

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

• The reviewers felt that the researchers should expand their discussion about the lack of diversity in their sample of participants and the implications this had on the generalizability of the study results. The researchers agreed that they could have used other recruitment strategies to try to recruit a more diverse group of participants, but some of these strategies were not possible during the COVID-19 pandemic. However, the researchers explained that they used the recruitment strategies that they felt were best accomplished in the timeframe of the study and met the milestone expectations of PCORI.
• The reviewers asked for more information about how the researchers calculated missing data. The researchers expanded their discussion of missing data management by listing how many items at pretest and at posttest were missing and had to be imputed.
• The reviewers also had questions about participant attrition and whether the researchers included people in their analysis sample who had not engaged in the interventions. The researchers explained that following the intent-to-treat principle they collected posttest and follow-up data on all possible participants, even if they did not engage in the intervention. Only nine participants were completely lost to follow-up.
• The reviewers asked for further explication of the Stress Appraisal Model, which the researchers identify as the basis for their intervention. The reviewers were unclear about whether the model includes more than one proximal and one distal outcome. The researchers explained that negative stress would be considered a proximal indicator, influencing the appraisal of caregiving. In turn, this negative appraisal of caregiving influences the caregiver’s psychological response through depression, anxiety or other mental health concerns.

This COVID-19 study's final enhancement report is expected to be available by February 2024.