A Technology-based Psychosocial Intervention to Support Social Engagement and Well-being in Older Adults With HIV
NCT Number: NCT06560970
Acronym: COPPEhR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV Diagnosis
Interventions: BEHAVIORAL: COPPEhR Intervention|BEHAVIORAL: Device-only Control Condition
Sponsor: Weill Medical College of Cornell University
Collaborators: National Institute on Aging (NIA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08
Completion Date: 2025-09
Locations: Weill Cornell Medicine, New York, New York, 10065, United States

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.

Primary Outcome Measures: Mean Difference of Perceived Usefulness and Perceived Ease of Use Questionnaire, Utilizing a 12-item scale (Perceived Ease of Use Questionnaire) which includes two subscales (perceived usefulness and perceived ease of use) with Likert response scales ranging from 1 (Strongly disagree) - 7 (Strongly agree). The total score ranges from 12 - 84. The responses to the items are summed for each of the subscales. Higher scores indicate perceived ease of use of the COPPEhR program., Post-randomization at month 3 and month 6|Mean Difference of System Evaluation Questionnaire, The COPPEhR system or device evaluation will be assessed by evaluating participants' perception of the features of the system. Utilizing an 11-item scale with Likert response scales ranging from 1 (Strongly disagree) - 5 (Strongly agree). The total score ranges from 11 - 55. Higher scores indicate higher degrees of satisfaction with the COPPEhR system, training, technical support., Post-randomization at month 3 and month 6
Secondary Outcome Measures: Mean Difference in Score of reported depression, assessed using the Center for Epidemiological Studies-Depression (CES-D) Scale, The CES-D is a self-report depression scale for research in general population. It is a 20 item questionnaire consisting of likert response scales ranging from 0-3 points. The total score range is 0 - 60 points. Higher scores indicate participants have a greater level of self reported depression., Post-randomization at Baseline, month 3, and month 6|Change in Loneliness as Measured by UCLA Loneliness Scale, To measure degree of loneliness. The 3rd version of the UCLA Loneliness Scale includes positively worded or non-lonely items. It is a 20 item questionnaire consisting of likert response scales ranging from 0-3 points. Higher score indicates a greater degree of loneliness. Range (0-60), Post-randomization at Baseline, month 3, and month 6|Mean Difference in Score of Quality of Life, assessed using The Quality of Life Questionnaire, Will assess the participant's quality of life by having the participant rate different aspects of their life using one of four words: poor, fair, good, or excellent. They are instructed to think about different aspects of their life, like physical health, energy, family, money, and others to assess their situation in each area.

The Quality of Life questionnaire is a 13-item scale with Likert response scales ranging between 1 and 4 points. The measure's total score can range between 13 - 52 points. A higher total score is reflective of a higher quality of life while a lower score is reflective of a poorer quality of life., Post-randomization at Baseline, month 3, and month 6|Mean Difference in score of participants self-reported health, assessed using the 36-Item Short Form Health Survey questionnaire (SF-36 Short Form), The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. The total measure scores range from 0 - 100. Lower scores = more disability, higher scores = less disability. The 8 subscales or domains are as follows: Physical functioning (10 items); Role limitations due to physical health (4 items); Role limitations due to emotional problems (4 items); Energy/fatigue (4 items); Emotional well-being (5 items); Social functioning (2 items); Pain (2 items); General health (5 items)., Post-randomization at Baseline, month 3, and month 6|Mean Difference in score of participants self-reported Resilience, assessed by BRS - Brief Resilience Scale, The BRS Brief Resilience Scale will assess a person's self-perceived ability to bounce back or recover from stress. This questionnaire/scale has six items. It uses a 5-point Likert scale with 5 response categories - Strongly Disagree, Somewhat Disagree, Neither Agree nor Disagree, Somewhat Agree and Strongly Agree. The total score ranges from 6 - 30. Higher scores indicates a greater level of resilience., Post-randomization at Baseline, month 3, and month 6|Mean Difference in Score of Social Support and Connectivity Assessed using The Social Connectedness Measure, Scales used to measure two aspects of social isolation: social disconnectedness and perceived isolation, as well as perceived availability of social support. The Social Connectedness measure is a 15-item scale consisting of 3 sections with different likert response scale. Section 1 is a 4 item scale ranging from 0 - 5 points (20 total points). Section 2 is a 6-item scale ranging from 1 - 3 points (18 total points). Section 3 is a 5-item scale ranging from 1 - 5 points (25 total points). The total score ranges from 11 - 63. A higher total score is reflective of increased connectedness, with items 5-7 and items 11-15 reverse scored. Total scores will be summed and then a mean difference in score will be calculated., Post-randomization at Baseline, month 3, and month 6|Social Engagement using the Lubben Social Network Index (LSNS-6), The Lubben Social Network Index (LSNS-6) will assess social engagement including family and friends. This scale has 6 items. The score is computed by adding the response of all items. The score ranges between 0-30 with higher scores indicating more social engagement., Post-randomization at Baseline, month 3, and month 6|Medical Outcome Study: Social Support Survey Instrument, This is a 19-item questionnaire that measures emotional/informational support, tangible support, affectionate support, positive social interaction, and one additional miscellaneous item. The survey/instrument consists of four separate social support subscales and an overall functional support index. The total score ranges from 19 - 95. A higher score for an individual scale or for the overall support index indicates more support., Post-randomization at Baseline, month 3, and month 6|Mean Difference in score of Social Isolation using the Friendship Scale, This questionnaire/scale has a total of 6 items measuring perceived social isolation. The time frame of the questions is set at 4 weeks. The scale used for this questionnaire is as follows: Almost always = "0"; Most of the time = "1"; About half the time = "2'; Occasionally = "3"; and Not at all = "4". The score range is 0-24. A high score represents social connectedness and a score of "0" indicates complete social isolation., Post-randomization at Baseline, month 3, and month 6