NCT06479707

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 7, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

June 13, 2024

Last Update Submit

March 13, 2026

Conditions

Keywords

LiteracyDigitalInterventionOlder AdultsTechnology

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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.

    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).

    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.

    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.

    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.

    Baseline, 9 weeks

Secondary Outcomes (5)

  • Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale

    Baseline, 9 weeks

  • Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living

    Baseline, 9 weeks

  • Change in Pain as assessed by the Brief Pain Inventory

    Baseline, 9 weeks

  • Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-2)

    Baseline, 9 weeks

  • Change in Frailty as assessed by the Fried Frailty Phenotype

    Baseline, 9 weeks

Other Outcomes (8)

  • Acceptability at endpoint of intervention assessed by survey

    9 weeks

  • Feasibility as assessed by qualitative questions

    9 weeks

  • Feasibility as assessed by recruitment rate

    9 weeks

  • +5 more other outcomes

Study Arms (1)

Pilot

OTHER
Behavioral: Digital Literacy Intervention

Interventions

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.

Pilot

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Melissa Hladek, PhD

    Johns Hopkins School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 28, 2024

Study Start

November 7, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations