RELOAD-C for Loneliness

Recruiting at 3 trial locations

Overseen By Michael Diefenbach, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Non-English speakers, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

96 Participants Needed

Trial Summary

What is the purpose of this trial?

More than 60% of care partners of persons with AD/ADRD report feeling lonely. Building on the existing evidence that increasing meaning and purpose in life is a strong predictor of decreased loneliness, interventions to reduce loneliness in this population may be strengthened by incorporating concepts from Meaning-Centered Psychotherapy (MCP). Thus, the overall goal of the proposed project is to reduce loneliness in care partners of patients with AD/ADRD through increasing their sense of meaning and purpose in life using concepts from MCP, delivered via a web-based platform, RELOAD-C (REducing LOneliness in Alzeheimer's Disease-Care Partners). This will be achieved through three Specific Aims. Aim 1 consists of three phases (preparatory work, stakeholder involvement with N=15 AD/ADRD care partners, and adaptation of the existing web-based platform) to produce RELOAD-C, which centralizes: 1) 6 brief videos portraying an MCP expert delivering MCP concepts; 2) links to 7 virtual group meetings (6 weekly + 1 booster) to discuss MCP concepts (of note, the support groups utilized in this study exist only as part of this research); and 3) written content expanding on the material from the MCP videos. Aim 2 evaluates usability/acceptability of RELOAD-C (defined as a task success rate ≥ 78%, and scores ≥ 68 on the System Usability Scale) with N=20 care partners of persons with AD/ADRD. Aim 3 proposes a pilot RCT to evaluate the preliminary efficacy of the RELOAD-C components (MCP videos vs. MCP-focused group discussions) in reducing loneliness and feasibility of conducting a future, large-scale RCT. N=96 AD/ADRD care partners will be randomized to: usual care, n=32; MCP videos alone via RELOAD-C, n=32; or MCP videos + weekly groups via RELOAD-C, n=32. Care partners' outcomes will be assessed at baseline, and 6-weeks and 3-months post-baseline. The investigators expect the effect sizes will be in the moderate range (.3). Feasibility is defined as: ≥ 75% consented, ≤ 30% drop-out, and 80% engagement with intervention. Reducing loneliness among care partners is of high public health significance and incorporating MCP in loneliness interventions is highly innovative. In sum, the investigators will enroll 15 care partners during Aim 1, 20 care partners during Aim 2, and 96 care partners during Aim 3.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on psychological support rather than medication changes.

What data supports the effectiveness of the treatment RELOAD-C for reducing loneliness in Alzheimer's disease care partners?

Research shows that loneliness is a common issue among older adults with chronic conditions, and addressing social support can help reduce feelings of isolation. This suggests that treatments like RELOAD-C, which focus on enhancing social connections, may be effective in reducing loneliness. ^{1 2 3 4 5}

What safety data exists for the RELOAD-C treatment for loneliness?

The research on social network interventions and mutual support groups for conditions like rheumatoid arthritis suggests these approaches are generally safe and can improve social functioning and perceived health without reported safety concerns. ^{6 7 8 9 10}

How is the RELOAD-C treatment for loneliness in Alzheimer's caregivers different from other treatments?

RELOAD-C is unique because it specifically targets loneliness in caregivers of people with Alzheimer's, focusing on improving their social connections and emotional well-being, which is not typically addressed by standard medical treatments. ^{3 11 12 13 14}

Eligibility Criteria

This trial is for adult care partners of community-dwelling persons with Alzheimer's disease or related disorders (AD/ADRD) who feel lonely, as indicated by a specific loneliness scale. Participants must not be professional caregivers but rather family members or friends, speak English, have the ability to use technology like email and internet, and their role cannot be linked to employment.

Inclusion Criteria

I am mentally capable of understanding and participating in the trial.

English-speaking

Report that their role as a care partner is not related to their employment (i.e. they are a family member or friend of the patient)

Exclusion Criteria

I cannot communicate in English.

Only one care partner per patient will be allowed to participate

Could not have participated in previous Aims (1 or 2) of this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Work

Modification of MCP scripts for AD/ADRD care partners and stakeholder feedback

4 weeks

2 rounds of feedback sessions

Usability and Acceptability Testing

Testing the usability and acceptability of the RELOAD-C platform with care partners

4 weeks

Multiple virtual sessions

Pilot RCT

Randomized controlled trial to evaluate the efficacy of MCP videos and group discussions

6 weeks

Weekly virtual group meetings

Follow-up

Participants are monitored for changes in loneliness, burden, and other outcomes

3 months

Assessments at 6 weeks and 3 months post-baseline

Treatment Details

Interventions

• RELOAD-C

Trial Overview The RELOAD-C program aims to reduce loneliness in AD/ADRD care partners by enhancing their sense of meaning and purpose through Meaning-Centered Psychotherapy (MCP). It includes videos on MCP concepts, virtual group meetings for discussion, and additional written content. The study will test these components' usability and effectiveness compared to usual care.

Participant Groups

Group I: Intervention Arm 2 Experimental Treatment 1 Intervention

MCP videos + MCP-focused virtual groups. In addition to the components that the intervention arm 1 participants receive (6 MCP videos, written text), the RELOAD-C platform for the intervention arm 2 participants will include links to the virtual group meetings (7 in total). The first 6 group meetings will occur weekly. Each of the first 6 group meetings will facilitate discussion of the MCP concepts introduced in that week's video, as participants receive access to each video \~3 days prior to the group meeting. The 7th virtual meeting will be used as a "booster" in week 9, and will focus on sharing how participants are using the MCP concepts in their daily lives. All meetings will be facilitated by our social worker, Katherine Henthorne, LCSW.

Group II: Intervention Arm 1 Experimental Treatment 1 Intervention

MCP videos alone. Care partners randomized to intervention arm 1 during Step 2 randomization will receive usual care + RELOAD-C, consisting of: 1) 6 brief (\~5 minute) videos of Dr. Allison Applebaum introducing concepts from MCP for care partners of persons with AD/ADRD; and 2) written content associated with the videos, such as directions for homework assignments. The tab with links to the virtual group meetings will be removed. Participants in this arm use RELOAD-C on their own and do not have interaction with other care partners while using the platform. One video will become available for viewing each week for the first 6 weeks after randomization, and each care partner will have a unique user ID/login.

Group III: Usual Care Active Control 1 Intervention

Usual care for AD/ADRD care partners consists of a screen for burden, and potential referral to AD/ADRD social workers and the AD helpline.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

In a study of 2,788 older adults aged 55 to 85, it was found that social network size and emotional support were generally similar across individuals with different chronic diseases, indicating that these factors may not be significantly influenced by disease status.

However, those with lung disease or arthritis reported higher levels of loneliness, while individuals with arthritis or stroke received more instrumental support, suggesting that specific chronic conditions can affect feelings of loneliness and the type of support received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social network, social support, and loneliness in older persons with different chronic diseases. Penninx, BW., van Tilburg, T., Kriegsman, DM., et al.[2017]

A study involving 70 people with early-stage dementia and 73 family carers revealed that maintaining familiar relationships is crucial for reducing feelings of loneliness in individuals with dementia.

The research highlights that simply placing people with dementia in new environments or with unfamiliar individuals may not alleviate loneliness, suggesting that personalized care strategies that consider social needs are essential for improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dementia and loneliness: an Australian perspective. Moyle, W., Kellett, U., Ballantyne, A., et al.[2011]

In a study of 454 adults with end-stage liver disease awaiting liver transplantation, 26% reported feeling lonely, highlighting the prevalence of loneliness in this patient population.

Factors such as younger age, female sex, physical frailty, not working, and being without a committed partner were significantly associated with higher odds of loneliness, suggesting that these characteristics may increase vulnerability to feelings of isolation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loneliness in adults awaiting liver transplantation at 7 U.S. transplant centers. Berry, KA., Kent, D., Seetharaman, S., et al.[2023]

Older adults with chronic conditions living at home experience significant loneliness, which is linked to negative emotions and unmet social needs.

To cope with their loneliness, these individuals employ self-strategies and seek social support, highlighting the importance of community and personal resilience in managing their emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The lived experiences of loneliness of older adults with chronic conditions aging at home: A qualitative systematic review and meta-aggregation. Shi, Y., Yang, Y., Wang, L., et al.[2023]

About one-third of older adults who died between 2004 and 2014 reported feeling lonely, and this loneliness was linked to a higher total symptom burden at the end of life, indicating that loneliness can negatively impact the quality of dying.

Lonely individuals were more likely to use life support and to die in nursing homes compared to their non-lonely counterparts, suggesting that loneliness may lead to more intense end-of-life care, highlighting the need for interventions to address loneliness in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship of Loneliness to End-of-Life Experience in Older Americans: A Cohort Study. Abedini, NC., Choi, H., Wei, MY., et al.[2021]

The feasibility study involving 9 pairs of peer mentors and mentees showed that early peer support significantly improved mentees' coping efficacy, social support, and overall quality of life related to arthritis, with clinically important effect sizes greater than 0.3.

Peer mentors also benefited from the experience, reporting increased self-efficacy and learning from their mentees, highlighting the value of peer support in enhancing the care for individuals with early inflammatory arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-to-peer mentoring for individuals with early inflammatory arthritis: feasibility pilot. Sandhu, S., Veinot, P., Embuldeniya, G., et al.[2021]

The network intervention for female patients with rheumatoid arthritis significantly increased their social network size and daily emotional support compared to the attention control group.

Patients in the network intervention group experienced reduced social dysfunction and improved overall health compared to those in the no-treatment control group, highlighting the importance of addressing social needs in clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of social network intervention for women with rheumatoid arthritis. Fyrand, L., Moum, T., Finset, A., et al.[2019]

In a study of 42 patients with adult onset Still's disease, the 24-month drug retention rates (DRRs) for tocilizumab (TCZ) and anakinra (ANK) were significantly higher (62.5% and 53.1%, respectively) compared to tumor necrosis factor inhibitors (TNFi) at 11.8%.

The study found that previous use of biologic therapies did not influence the retention rates of the current treatments, suggesting that both TCZ and ANK are effective options for managing AOSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug retention rates of biological agents in adult onset Still's disease. Campochiaro, C., Farina, N., Tomelleri, A., et al.[2021]

In a study involving 112 patients with chronic rheumatic disorders, mutual support groups improved social skills, particularly in reducing distress when expressing negative feelings towards others, although this effect did not last long-term.

Patients who attended at least 5 out of 10 sessions reported an increase in expressing positive feelings towards others, indicating that regular participation in these groups can enhance social interactions and is beneficial for those struggling with social communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mutual support groups in rheumatic diseases: Effects and participants' perceptions. Savelkoul, M., de Witte, LP.[2019]

In a study of 229 out-patients with rheumatoid arthritis, fatigue was significantly correlated with pain, self-efficacy in coping with RA, and problematic social support, explaining 37% of the variation in fatigue levels.

Patients with higher self-efficacy regarding coping and seeking help experienced less fatigue, suggesting that enhancing self-efficacy through self-management courses could potentially improve fatigue in RA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue in rheumatoid arthritis: the role of self-efficacy and problematic social support. Riemsma, RP., Rasker, JJ., Taal, E., et al.[2022]

The pilot study focused on older residents in rural Virginia with chronic illnesses, highlighting the significant impact of loneliness on their medication adherence and disease management.

Findings suggest that loneliness negatively affects the quality of life for these individuals, indicating a need for interventions that address social isolation alongside medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loneliness and quality of life in chronically ill rural older adults. [2017]

In a study of 1283 family caregivers of people with mild-to-moderate dementia, 43.7% reported moderate loneliness and 17.7% reported severe loneliness, highlighting a significant prevalence of loneliness in this group.

Factors such as greater social isolation and caregiving stress were linked to higher levels of loneliness, while better relationships with the person with dementia and higher well-being were associated with lower loneliness, suggesting that interventions should focus on reducing stress and enhancing caregiver relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence and predictors of loneliness in caregivers of people with dementia: findings from the IDEAL programme. Victor, CR., Rippon, I., Quinn, C., et al.[2021]

The study involved 37 dying cancer patients, 78 caregivers, and 128 individuals from the general population, revealing that both dying patients and their caregivers experience loneliness differently than the general population, particularly in terms of growth and self-alienation.

Dying patients and caregivers reported significantly higher feelings of growth and discovery, as well as self-alienation, compared to the general population, indicating that their unique circumstances influence their experience of loneliness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The loneliness experience of the dying and of those who care for them. Rokach, A., Matalon, R., Safarov, A., et al.[2019]

A study involving 295 older adults (average age 74.3 years) showed that participating in 6-week Chronic Disease Self-Management Education (CDSME) workshops significantly reduced feelings of loneliness (p < 0.001).

The interactive nature of the CDSME workshops likely contributed to these reductions in loneliness by fostering connections among participants who share similar chronic health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of chronic disease self-management education (CDSME) programs to reduce loneliness. Smith, ML., Chen, E., Lau, CA., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Social network, social support, and loneliness in older persons with different chronic diseases. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Dementia and loneliness: an Australian perspective. [2011]

3. Mexico pubmed.ncbi.nlm.nih.gov

Loneliness in adults awaiting liver transplantation at 7 U.S. transplant centers. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The lived experiences of loneliness of older adults with chronic conditions aging at home: A qualitative systematic review and meta-aggregation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Relationship of Loneliness to End-of-Life Experience in Older Americans: A Cohort Study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Peer-to-peer mentoring for individuals with early inflammatory arthritis: feasibility pilot. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The effect of social network intervention for women with rheumatoid arthritis. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Drug retention rates of biological agents in adult onset Still's disease. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Mutual support groups in rheumatic diseases: Effects and participants' perceptions. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Fatigue in rheumatoid arthritis: the role of self-efficacy and problematic social support. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Loneliness and quality of life in chronically ill rural older adults. [2017]

12. England pubmed.ncbi.nlm.nih.gov

The prevalence and predictors of loneliness in caregivers of people with dementia: findings from the IDEAL programme. [2021]

13. England pubmed.ncbi.nlm.nih.gov

The loneliness experience of the dying and of those who care for them. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of chronic disease self-management education (CDSME) programs to reduce loneliness. [2023]