Clinical trial NCT06560970: A Technology-based Psychosocial Intervention to Support Social Engagement and Well-being in Older Adults With HIV
Official title: A Technology-based Psychosocial Intervention to Support Social Engagement and Well-being in Older Adults With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Diagnosis
Keywords: Technology
Computer
Social Engagement
Well-being
Older Adults
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-08-19
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Older people with HIV (OPH) often live with significant mental health challenges such as social isolation, loneliness, and depression. The objectives of this study are to develop and test the usability and feasibility of a technology-based psychosocial intervention program designed to: enhance social engagement and support; facilitate resource access and education; reduce loneliness; and improve well-being among older adults with HIV who are long-term survivors (diagnosed with HIV ≥ 20 years). The program, Connecting Older Positive People to Enhance Health and Resilience (COPPEhR), will build on Dr. Sara Czaja's PRISM (A Personal Reminder and Information Management System for Seniors) platform, and will be an easy-to-use software application (app), preloaded onto a standard device, designed to support social connectivity, memory, and access to resources for older adults at risk for isolation and the programs and services available at the Center for Special Studies (CSS) at Weill Cornell Medicine (WCM). This protocol covers Phase 2 of the study, which will be a pilot randomized controlled efficacy trial will compare the COPPEhR intervention to a device-only control condition. Participants in the control condition will receive the same device as those in the COPPEhR condition without the COPPEhR application. The specific aims of this developmental project are to evaluate the feasibility, usefulness, and usability of a state-of-the art technology-based multicomponent COPPEhR intervention for aging adults with HIV. Our hypothesis is the COPPEhR intervention will be feasible, usable and useful. The hypothesis is that those that use the COPPEhR app will experience less loneliness, less depression, and less social isolation and more social support, more resilience, and more connectivity than those that do not use the COPPEhR app.

Detailed description: The development of modern antiretroviral therapies has increased the life expectancy of people living with HIV (PLWH) allowing them to survive into older ages. Older people with HIV (OPH) have an enhanced risk of developing multiple chronic conditions, such as cardiovascular disease, kidney and liver disease, cancer, and cognitive impairment. Also, especially for those who had treatment early, HIV remains stigmatized. OPH live with significant mental health interdependent challenges such as social isolation, loneliness, and depression. Because of stigma and protective withdrawal behaviors, OPH also tend to have limited social networks and opportunities for engagement. In a recent study of people ≥ 50 years of age with HIV, 58% of the sample (N=356) reported experiencing loneliness. Moore and colleagues, found that older adults with HIV in their sample spent a considerable amount of time at home alone engaged in solitary activities.

The consequences of social isolation include lower quality of life and life satisfaction and poorer mental, physical, and cognitive health. With respect to OPH, studies have shown that loneliness is associated with substance abuse, depression, and poorer quality of life. So-Armah and colleagues, using data from the Veterans Aging Cohort study, found that depressive symptoms were associated with all-cause mortality among US veterans with HIV but not among those without HIV infection. To date, there has been limited intervention research directed at psychosocial issues among OPH, especially long-term survivors. In fact, a recent systematic review of psychosocial interventions for older adults with HIV/AIDS found a paucity of psychosocial interventions and few randomized trials and highlighted a need for home-based interventions to enhance the quality of life for adults aging with HIV. As noted by the National Institutes of Health Office of AIDS Research Working Group on HIV \& Aging, research focused on social isolation and behavior is critical for this population.

Technology-based interventions provide a potential solution for enhancing access to instrumental and social support for older adults with HIV and offer unparalleled flexibility in information presentation and facilitates broad implementation of applications. As noted by a recent report from the National Academies of Science, Engineering, and Medicine that focused on social isolation, "technology provides an important set of opportunities for the 'toolkit' of strategies that can help prevent or mitigate social isolation and loneliness in older adults (pg. 9-38)." Studies have examined the impact of access to the Internet on well-being and social outcomes for older adults, and the results are encouraging. For example, use of the Internet was shown to decrease loneliness and increase social contact among a sample of higher use of social technology was linked to higher ratings of health and well-being and lower depressive symptoms. The links between use of social technology and these outcomes were mediated by reductions in loneliness. The investigators conducted an randomized control trial (RCT) that evaluated PRISM, a software system that supports social connectivity, memory, and information access, with older adults at risk for social isolation. Findings indicated that use of PRISM resulted in significantly less loneliness, increased social support and well-being, and an increase in device comfort and proficiency at 6 months.

Recent studies support the importance and acceptability of using technology for aging adults with HIV. Moore and colleagues8 found that older adults with HIV were able to use smart phones to collect ecological momentary assessment data. Findings from a recent study indicated that OPH that participated in an online mindfulness intervention showed reductions in depression, anxiety, and loneliness. The objectives of this proposed development study are to develop and evaluate a technology-based psychosocial intervention, Connecting Older Positive People to Enhance Health and Resilience (COPPEhR), designed to increase social and cognitive engagement and resource access, reduce loneliness, and improve well-being among OPH. COPPEhR will be delivered on a device via an app and the features will be guided by Activity Theory, models of Successful Aging, and Social Engagement, which underscore that social and cognitive engagement are integral to successful aging and that the benefits of social and meaningful engagement include better emotional, physical and cognitive health.

In accordance with these theories, the features of COPPEhR will provide opportunities for social support and connection, social network expansion (e.g., online support groups, buddies/interest groups) and expansion of social capital (community feature) which the investigators postulate will enhance social engagement, which will in turn be linked to less loneliness and better well- being (e.g., less depression) COPPEhR will also be based on our prior NIH funded work; services available at the Center for Special Studies (CSS), which has a clinic for OPH; the resources of the Center on Aging and Behavioral Research (CABR) (Czaja, Director); and the Center for Research and Education on Aging and Technology Enhancement (CREATE) (Czaja, PI).

Eligibility criteria: Inclusion Criteria:

1. Age 50+
2. HIV diagnosis for at least 20 years
3. Center for Special Studies (CSS) patient
4. Able to read English at 6th grade level
5. Visually able to read a device screen
6. Adequate cognitive status (score above 37) to interact with the technology assessed by the Telephone Interview for Cognitive Status - modified (TICS-M)
7. Plan to remain in the area for the next 9 months

Exclusion Criteria:

1. Not a Center for Special Studies (CSS) patient
2. Blind or have visual impairments that limit their ability to view the technology
3. Deaf or have hearing impairments that limit their ability to use the technology
4. Has a mobility or dexterity impairment that would interfere with the use of a device, mouse, or a keyboard (e.g., tremors, arthritis, etc.)
5. Severe psychosis (e.g., aggression)
6. Severe cognitive impairment that limits their ability to use the technology
7. Participants who do not meet the inclusion criteria.
8. Participants in previous COPPEhR usability testing

Primary outcomes:
measure: Mean Difference of Perceived Usefulness and Perceived Ease of Use Questionnaire
timeFrame: Post-randomization at month 3 and month 6
measure: Mean Difference of System Evaluation Questionnaire
timeFrame: Post-randomization at month 3 and month 6
Secondary outcomes:
measure: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale
timeFrame: Post-randomization at Baseline, month 3, and month 6
measure: Change in Loneliness as Measured by UCLA Loneliness Scale
timeFrame: Post-randomization at Baseline, month 3, and month 6
measure: Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire
timeFrame: Post-randomization at Baseline, month 3, and month 6
measure: Mean Difference in score of participants self-reported health, assessed using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form)
timeFrame: Post-randomization at Baseline, month 3, and month 6
measure: Mean Difference in score of participants self-reported Resilience, assessed by BRS - Brief Resilience Scale
timeFrame: Post-randomization at Baseline, month 3, and month 6
measure: Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure
timeFrame: Post-randomization at Baseline, month 3, and month 6
measure: Social Engagement using the Lubben Social Network Index (LSNS-6)
timeFrame: Post-randomization at Baseline, month 3, and month 6
measure: Medical Outcome Study: Social Support Survey Instrument
timeFrame: Post-randomization at Baseline, month 3, and month 6
measure: Mean Difference in score of Social Isolation using the Friendship Scale
timeFrame: Post-randomization at Baseline, month 3, and month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sara Czaja, PhD
role: PRINCIPAL_INVESTIGATOR
References: