Quality of LifeNCT06479707
Digital Literacy Intervention to Address Support, Literacy and Communication in Older Adults
A study testing Digital Literacy Intervention in people with Quality of Life and Aging, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Quality of Life, Aging, Technology
- What is being tested?
- Digital Literacy Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years old or older
- English proficient
- Willingness to improve digital literacy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: Digital Literacy Pilot Intervention to Address Support, Literacy and Communication in Older Adults
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.
Read the 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.
- Conditions
- Quality of Life, Aging, Technology, Literacy
- Being tested
- Digital Literacy Intervention
- Keywords
- Literacy, Digital, Intervention, Older Adults, Technology
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Literacy InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot | Other | Not described Receives: Behavioral: Digital Literacy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 9 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start7 Nov 2024
- Primary completion30 Mar 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Melissa Hladek, PhD, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479707
- Sponsor's protocol ID
- IRB00437921
- Other IDs
- P30AG021334-21
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hladek MD, Rubio OC, Curriero S, Horn S, Hughes A, Wilson DH, McAdams-DeMarco M, Crews DC, Szanton SL. Empowering Older Adults Through Values-Informed Solutions for Technology Adoption: Protocol for a Feasibility and Acceptability Randomized Controlled Pilot Trial. JMIR Res Protoc. 2026 May 21;15:e85257. doi: 10.2196/85257.
PubMed 42166781
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Literacy Pilot Intervention to Address Support, Literacy and Communication in Older Adults
- ClinicalTrials.gov ID
- NCT06479707
- Acronym / sponsor ID
- IRB00437921
- Conditions
- Quality of Life, Aging, Technology, Literacy
- Keywords
- Literacy, Digital, Intervention, Older Adults, Technology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot | Other | Behavioral: Digital Literacy Intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 years old or older
- English proficient
- Willingness to improve digital literacy
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Literacy InterventionThis 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. | Behavioural | Pilot |
Primary outcome
Change in Health Team Communication as assessed by the CollaboRATE Scale Measure
Time frame: Baseline, 9 weeks
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.
Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument
Time frame: Baseline, 9 weeks
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.
Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument
Time frame: Baseline, 9 weeks
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.
Change in Social engagement as assessed by the Lubben Social Network Scale
Time frame: Baseline, 9 weeks
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.
Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale
Time frame: Baseline, 9 weeks
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.
Change in quality of life as assessed by the European Quality of Life (Euro-QOL-5D)
Time frame: Baseline, 9 weeks
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).
Change in health literacy as assessed by the Rapid Estimate of Adult Literacy in Medicine (REALM)
Time frame: Baseline, 9 weeks
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.
Change in digital health literacy as assessed by the Digital Health Care Literacy Scale
Time frame: Baseline, 9 weeks
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.
Change in digital health literacy as assessed by the Mobile Device Proficiency Questionnaire (MDPQ)
Time frame: Baseline, 9 weeks
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.
5 secondary outcomes
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
Time frame: Baseline, 9 weeks
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
Time frame: Baseline, 9 weeks
Change in Pain as assessed by the Brief Pain Inventory
Time frame: Baseline, 9 weeks
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-2)
Time frame: Baseline, 9 weeks
Change in Frailty as assessed by the Fried Frailty Phenotype
Time frame: Baseline, 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 42166781Hladek MD, Rubio OC, Curriero S, Horn S, Hughes A, Wilson DH, McAdams-DeMarco M, Crews DC, Szanton SL. Empowering Older Adults Through Values-Informed Solutions for Technology Adoption: Protocol for a Feasibility and Acceptability Randomized Controlled Pilot Trial. JMIR Res Protoc. 2026 May 21;15:e85257. doi: 10.2196/85257.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Hladek, PhD principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Literacy Intervention in people with Quality of Life and Aging, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Team Communication as assessed by the CollaboRATE Scale Measure (time frame: Baseline, 9 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.