Clinical trial NCT06479707: Digital Literacy Intervention to Address Support, Literacy and Communication in Older Adults
Official title: Digital Literacy Pilot Intervention to Address Support, Literacy and Communication in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Life
Aging
Technology
Literacy
Keywords: Literacy
Digital
Intervention
Older Adults
Technology
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 65 years old or older
* English proficient
* Willingness to improve digital literacy

Exclusion Criteria:

* Severe cognitive impairment as defined by a 6-item Callahan Cognitive Screener
* Hospitalization overnight more than 3 times in the last 12 months by self-report.

Primary outcomes:
measure: Change in Health Team Communication as assessed by the CollaboRATE Scale Measure
timeFrame: Baseline, 9 weeks
measure: Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument
timeFrame: Baseline, 9 weeks
measure: Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument
timeFrame: Baseline, 9 weeks
measure: Change in Social engagement as assessed by the Lubben Social Network Scale
timeFrame: Baseline, 9 weeks
measure: Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale
timeFrame: Baseline, 9 weeks
measure: Change in quality of life as assessed by the European Quality of Life (Euro-QOL-5D)
timeFrame: Baseline, 9 weeks
measure: Change in health literacy as assessed by the Rapid Estimate of Adult Literacy in Medicine (REALM)
timeFrame: Baseline, 9 weeks
measure: Change in digital health literacy as assessed by the Digital Health Care Literacy Scale
timeFrame: Baseline, 9 weeks
measure: Change in digital health literacy as assessed by the Mobile Device Proficiency Questionnaire (MDPQ)
timeFrame: Baseline, 9 weeks
Secondary outcomes:
measure: Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
timeFrame: Baseline, 9 weeks
measure: Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
timeFrame: Baseline, 9 weeks
measure: Change in Pain as assessed by the Brief Pain Inventory
timeFrame: Baseline, 9 weeks
measure: Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-2)
timeFrame: Baseline, 9 weeks
measure: Change in Frailty as assessed by the Fried Frailty Phenotype
timeFrame: Baseline, 9 weeks
Other outcomes:
measure: Acceptability at endpoint of intervention assessed by survey
timeFrame: 9 weeks
measure: Feasibility as assessed by qualitative questions
timeFrame: 9 weeks
measure: Feasibility as assessed by recruitment rate
timeFrame: 9 weeks
measure: Feasibility as assessed by completion rate
timeFrame: 9 weeks
measure: Feasibility as assessed by mean time for survey administration
timeFrame: 9 weeks
measure: Feasibility as assessed by withdrawal rate
timeFrame: 9 weeks
measure: Feasibility as assessed by average cost
timeFrame: 9 weeks
measure: Fidelity as assessed by percent completion of intervention items at endpoint of intervention
timeFrame: through study completion, an average of 1.5 years
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Melissa Hladek, PhD
role: PRINCIPAL_INVESTIGATOR
References: