An interventional study of Digital Literacy Intervention in Quality of Life, Aging and Technology, sponsored by Johns Hopkins University. Active, not recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Supportive care
The investigators propose a person-directed, values-based digital literacy intervention to address the community-identified barriers of health literacy, health communication and social support to improve quality of life and specific disease related metrics in the older adult's own home. This intervention will be a way to address the community-identified barriers of health literacy, health communication and social support to improve quality of life and specific disease related metrics in the older adult's own home.
This is a one-arm pilot trial to test the feasibility and acceptability of the intervention Digital Literacy Pilot Intervention to Address Support, Literacy and Communication in Older Adults. Each participant will receive 4-6 home visits with 3-4 interim phone calls based on the participant's individual digital literacy needs and goals. Each participant will receive internet connectivity (if not already available), a tablet (if not already available) and tailored action plans co-developed by the participant and the interventionist. In each participant will also have pre and post-intervention visits with the research team.
In earlier phases, research team members conducted preliminary activities to design the intervention using Human-Centered Design techniques.
201 studies on the registry are indexed under Literacy; 69 are open to participants now.
This study's planned enrollment of 20 is below the median of 124 across 170 interventional studies indexed under Literacy.
Browse Literacy studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Digital Literacy Intervention
This intervention consists of 4-6 home visits with 3-4 interim phone calls based on the participant's individual digital literacy needs and goals. Each participant will receive internet connectivity (if not already available), a tablet (if not already available) and tailored action plans co-developed by the participant and the interventionist.
Change in Health Team Communication as assessed by the CollaboRATE Scale Measure
The CollaboRATE scale measure is a 3 item self-report questionnaire on patient's shared decision making. It is scored on a 10-point anchored scale, ranging from 0 ("no effort was made") to 9 ("every effort was made"). Higher scores indicate more shared decision making.
Time frame: Baseline, 9 weeks
Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument
Coping Self-Efficacy is a 13 item instrument on a scale of 0 ('can't do at all') to 10 ('certain can do'). A higher score indicates higher level of self-efficacy when implementing coping strategies. Score range 0-130.
Time frame: Baseline, 9 weeks
Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument
Self-Efficacy of Chronic Disease Management Instrument is a 6 item instrument on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Lower scores indicate lower self-efficacy as indicated by confidence. Score range 6-60.
Time frame: Baseline, 9 weeks
Change in Social engagement as assessed by the Lubben Social Network Scale
The Lubben Social Network Scale is a 7-item questionnaire that measures the size of social networks of family and friends. The score ranges between 0 and 30, with higher scores indicated more social engagement.
Time frame: Baseline, 9 weeks
Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale
The Krause-Borawski-Clark Support Interactions Scale is a 10-item self-reported questionnaire that measures social interactions. The scale is broken down into different domains; scores range from very often (4); fairly often (3); once in a while (2); never (1) or binary-- satisfied (1) or not satisfied (0) depending on domain within the questionnaire. Items are summed to form a single composite score range 10-40, Higher scores on the scale is associated with better personal perception and social support.
Time frame: Baseline, 9 weeks
Change in quality of life as assessed by the European Quality of Life (Euro-QOL-5D)
The Euro-QOL-5D is a self-report measure that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Response choices are severe, moderate or none (levels of disability) across domains. Questionnaire also includes a Visual Analog Scale, where respondents report their perceived health status ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time frame: Baseline, 9 weeks
Change in health literacy as assessed by the Rapid Estimate of Adult Literacy in Medicine (REALM)
The REALM screening tool assesses ability for respondent to correctly pronounce a list of common medical words and lay terms using the REALM Patient Word List. A score of 0-18 is 3rd grade and below, score of 19-44 is 4th to 6th grade, score of 45-60 is 7th to 8th grade, and a score of 61-66 is high school or above.
Time frame: Baseline, 9 weeks
Change in digital health literacy as assessed by the Digital Health Care Literacy Scale
The Digital Health Care Literacy scale is a 3-item questionnaire. Response options ranged from strongly disagree (0 points) to strongly agree (4 points). Total possible score options ranged from 0-12. Higher scores indicated higher digital health care literacy.
Time frame: Baseline, 9 weeks
Change in digital health literacy as assessed by the Mobile Device Proficiency Questionnaire (MDPQ)
The MDPQ is a 16-item questionnaire divided into 8 sub-scales. All items are on a 5-point scale with choices never tried (1), not at all (2), not very easily (3), somewhat easily (4), and to very easily (5). A low score indicates low mobile device proficiency.
Time frame: Baseline, 9 weeks
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
The assessment contains 8 questions with answers that are either a score of 0 or 1. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men to avoid potential gender bias.
Time frame: Baseline, 9 weeks
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
6 questions, each 1 point for a total score of 6. A score closer to 6 indicates high patient independence.
Time frame: Baseline, 9 weeks
Change in Pain as assessed by the Brief Pain Inventory
The Brief Pain Inventory - is a 4-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain. Score range 0-40.
Time frame: Baseline, 9 weeks
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-2)
The PHQ-2 is a item self-reported questionnaire to assess frequency of depression. The total score ranges from 0-6. A score of 3 or greater signifies that major depressive disorder is likely.
Time frame: Baseline, 9 weeks
Change in Frailty as assessed by the Fried Frailty Phenotype
The Fried Frailty Phenotype contains 5 criteria: unintentional weight loss \>10lbs \>5% of body mass in the last year, weakness (handgrip strength measurement), exhaustion (based on the Center for Epidemiological Studies Depression Scale), slow gait (walking time over a distance), and low physical activity. People who had none of the criteria were considered non-frail, people who had 1 and 2 criteria were considered pre-frail, and people who had ≥3 criteria were considered frail.
Time frame: Baseline, 9 weeks
Acceptability at endpoint of intervention assessed by survey
Score on Likert scale-based questions re: program content \& structure satisfaction, willingness to recommend. Survey developed by study team.
Time frame: 9 weeks
Feasibility as assessed by qualitative questions
Open/ Close Ended Questions. Questions developed by study team.
Time frame: 9 weeks
Feasibility as assessed by recruitment rate
Recruitment Rate. Measured by how many people recruited over designated period of time Mean time for survey administration, Withdrawal Rate, Cost. Questions developed by study team.
Time frame: 9 weeks
Feasibility as assessed by completion rate
Measured by how many people complete the intervention over designated period of time
Time frame: 9 weeks
Feasibility as assessed by mean time for survey administration
Mean time for survey administration measured by the average time it takes data collector to administer survey to participants
Time frame: 9 weeks
Feasibility as assessed by withdrawal rate
Withdrawal Rate. Measured by how many people withdrawal from the intervention over designated period of time
Time frame: 9 weeks
Feasibility as assessed by average cost
Cost. measured by average cost to deliver the intervention per person
Time frame: 9 weeks
Fidelity as assessed by percent completion of intervention items at endpoint of intervention
% tasks/ patient- directed content delivery per session
Time frame: through study completion, an average of 1.5 years
Plan to share: No
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Ran from Nov 2024 to primary completion in Mar 2026, 16 months.
Of 115 non-industry interventional studies with no phase under Literacy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 20. This study's 16 months is above that.
Counting every sponsor, half of 117 studies reached it within 11 months; a quarter within 4 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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