Dual Sensory Impairment of Vision and HearingLVRNCT03664349
Dual Sensory Impairment Low Vision Rehabilitation (LVR) Initiative
An observational study of Dual Sensory Impairment of Vision and Hearing, run by Johns Hopkins University at 1 site in United States.
Trial summary
The aims of the Improving Communication with Formal/Informal Caregivers among Older Adults with Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic (LVR) are: Primary aims Aim 1 To characterize prevalence of objective hearing impairment (i.e. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dual Sensory Impairment of Vision and Hearing
- What is being tested?
- SuperEar9000
- Type of treatment
- Medical device
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2018to 20 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aim 1 and Aim 2: 100 participants (convenience sample) and their identified people who assist with two or more ADLs/IADLs recruited from Wilmer Eye Institute's LVR clinic Aim 3: sub-cohort of 10 participants with dual sensory impairment and their identified people who assist with two or more ADLs/IADLs
Who may be able to join
- To be eligible for aims 1 \& 2 of the study, older adult participants must meet all of the following criteria:
- Age over 60 years. Individuals aged over 60 years at the time of recruitment are eligible for participation.
- Low Vision Rehab Patient/Attendee
- Fluent English Speaker
- Caregiver who reports aiding in 2 or More ADLs/IADLs.
- Residency. Participants must plan to reside in the local area for the pilot duration
Show all 13Show fewer
- Willingness to participate and adhere to the protocol. Participants must be willing and able to consent to participate in the study, be willing to adhere to the pilot protocol for the duration of the pilot (1 session for aim 1 and aim 2, 2 sessions 4-6 weeks apart for aim 3).
- To be eligible for aim 3 of the study, older adult participants must meet the following additional criteria:
- Dual Sensory Impairment (only for aims 2 and 3)
- Hearing Impairment. Participant hearing will be measured by pure tone audiometry a four-frequency test in both ears. Hearing impairment score >=25dB in better ear.
- Caregiver (Identified People who Assist with Two or More ADLs/IADLs) Participants
- To be eligible for aims 2 \& 3 of the study, caregiver participants must meet the following criteria:
- Assist an eligible and willing older adult pilot participant with two or more ADLs/IADLs.
Who cannot join
- Potential candidates for enrollment who meet one or more of the following criteria are excluded from participation in the study:
- Medical contraindication to use handheld amplifier. Because hearing amplifier will be the primary device used in the hearing intervention, participants with medical contraindications to hearing amplifier use are excluded. Contraindication will be determined by pilot audiologist. These may include:
- Active ear infection
- Atresia
- Profound hearing loss beyond the limits of the device
- Asymmetrical hearing loss
Show all 10Show fewer
- Central hearing loss (i.e. neurologic in origin)
- Free from Vision Impairment. Participants will be excluded who have no vision impairment after refraction on acuity, visual field status and contrast sensitivity as assessed by a low vision rehabilitation clinician.
- Depression. Screened with Center for Epidemiological Studies-Depression (CES-D) score ≥16.
- No participants are excluded based on race or sex.
Trial locations and contacts
1 site in 1 country.
United States1 site
Low Vision Rehabilitation Clinic, Johns Hopkins
Baltimore, Maryland, 21205
About this study
Official title: Improving Communication With Formal/Informal Caregivers Among Older Adults With Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic Pilot
The aims of the Improving Communication with Formal/Informal Caregivers among Older Adults with Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic (LVR) are:
Primary aims Aim 1 To characterize prevalence of objective hearing impairment (i.e. DSI) among a clinical LVR population) in older adults (≥60 years) with English proficiency free from moderate to severe depression or cognitive decline using the Hearing Handicap Inventory for the Elderly (HHIE) assessment and an objective hearing evaluation.
Read more
Aim 2 To describe the perceived burden of care on primary caregiver (identified people who assist with two or more activities of daily living. instrumental activities of daily living (ADLs/Instrumental activities of daily living (IADLs))of individuals with dual sensory impairment (DSI) among a clinical LVR population in older adults (≥60 years) with English proficiency free from moderate to severe depression or cognitive decline using the Zarit Burden Interview questionnaire and qualitative interview data analyses.
Aim 3 To determine feasibility and benefit of a pilot manualized over-the-counter hearing intervention program on LVR patients to address communication among a DSI population using the Zarit Burden Interview questionnaire.
3A: Describe feasibility based on completion of pilot, drop-out rate, and semi-structured interviews 3B: Describe perceived communication improvements based on semi-structured interviews
Read the detailed description
The pilot is a prospective cohort study. Approximately 100 participants and their identified people who assist with two or more ADLs/IADLs will be assessed for DSI prevalence and DSI impact on communication. A sub-cohort of 10 participants with DSI will be provided a hearing intervention and followed for 4-6 weeks to assess the over-the-counter hearing intervention program's impact on communication among a DSI population and its identified people who assist with two or more ADLs/IADLs.
Recruitment will be based at the Wilmer Eye Institute (East Baltimore location) LVR clinic. Recruitment efforts will focus on older adults (≥60 years) with English proficiency attending the LVR clinic. Caregivers will be identified based on self-report assistance with at least two ADLs and/or IADLs.
The hearing intervention, for the sub-cohort of 10 individuals with DSI and their identified people who assist with two or more ADLs/IADLs, consists of instruction and best-practices provided by an occupational therapist on the utilization of a handheld amplifier (SuperEar SE9000). Prior to the LVR session with the handheld amplifier, individuals with DSI will complete a daily functioning (ADLs/IADLs) questionnaire (a measure of LVR success). The occupational therapist will give participant a handheld amplifier (SuperEar SE9000) and provide instruction on device use and best-practices (i.e. reducing background noise) to improve communication for the patient-caregiver pairs.
Participant-caregiver pairs will utilize the device and communication strategies over a 4-6-week period between LVR visits. Upon return, pairs will complete semi-structured interviews to elicit information about utilization (successes, barriers), impact on communication, and open qualitative feedback. Participants and caregivers will complete post-intervention functioning questionnaire and Zarit Burden Interview, respectively.
- Being tested
- SuperEar9000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuperEar9000Device
Handheld hearing amplifier, not FDA regulated.
| Study group | Role | What they receive |
|---|---|---|
| Older Adult Participants and Informal/Formal Caregiver Pairs | A sub-cohort of approximately 10 participant-caregiver pairs will utilize SE9000 and communication strategies over a 4-6-week period between LVR visits. Receives: Device: SuperEar9000 | |
| Older Adult Participants | The pilot cohort of approximately 100 adults over age 60, with vision impairment, will complete the Hearing Handicap Inventory for the Elderly (HHIE), an assessment of perceived impact of hearing impairment, and an objective hearing evaluation. | |
| Formal/Informal Caregivers | Identified persons who assist willing and eligible older adult pilot participants with two or more ADLs/IADLs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Dual Sensory Impairment
Measured by the Hearing Handicap Inventory for the Elderly (HHIE), an assessment of perceived impact of hearing impairment, and an objective hearing evaluation (by pure tone audiometry a four-frequency test in both ears. Hearing impairment score >25dB in better ear).
Total HHIE score: summation of 10 items (0, 2 or 4 points per item, total score range 0 to 40).
0-8 = no handicap; 10-24 = mild to moderate handicap; 26-40 = severe handicap.
Measured: 1 day
Secondary outcomes (3)
Impact of Dual Sensory Impairment on Formal/informal Caregivers by 12 Question Zarit Burden Interview Questionnaire (Range 0-48, 0-10 mild burden, 10-20 mild to moderate burden, >20 high burden)
Caregivers defined as identified people who assist with two or more ADLs/IADLs). Impact measured by a 12 item Zarit Burden Interview Questionnaire(ZBI-12) to assess burden of care. Total ZBI-12 score: summation of 12 items (0 to 4 points per item, total score range 0 to 48).
- 0-10: no to mild burden
- 10-20: mild to moderate burden
- >20: high burden
Measured: 1 day
Feasibility of Handheld Amplifier on Communication with Formal/Informal Caregivers as assessed by Semi Structured Interviews
Feasibility will be measured by semi-structured dyad interviews conducted with formal/informal caregiver and older adult participant pairs. Feasibility will then be determined qualitatively based on participants' response to the interview questions.
Measured: 4-6 Weeks
Impact of Handheld Amplifier on Caregiver Burden with Formal/Informal Caregivers as assessed by Zarit Burden Interview Questionnaire
Impact of hearing amplifier on dyad caregiver burden will be measured with ZBI-12. Total ZBI-12 score: summation of 12 items (0 to 4 points per item, total score range 0 to 48).
- 0-10: no to mild burden
- 10-20: mild to moderate burden
- >20: high burden
Measured: 4-6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start26 Nov 2018
- Primary completion1 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual Sensory Impairment of Vision and HearingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Reed, AuD, Principal investigator, Johns Hopkins Bloomberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664349
- Sponsor's protocol ID
- IRB00183648
- Other IDs
- LVR-F-1
- Acronym
- LVR
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Communication With Formal/Informal Caregivers Among Older Adults With Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic Pilot
- ClinicalTrials.gov ID
- NCT03664349
- Acronym / sponsor ID
- LVR / IRB00183648
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 10 Sep 2018 (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 aims of the Improving Communication with Formal/Informal Caregivers among Older Adults with Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic (LVR) are:
Primary aims Aim 1 To characterize prevalence of objective hearing impairment (i.e. DSI) among a clinical LVR population) in older adults (≥60 years) with English proficiency free from moderate to severe depression or cognitive decline using the Hearing Handicap Inventory for the Elderly (HHIE) assessment and an objective hearing evaluation.
Aim 2 To describe the perceived burden of care on primary caregiver (identified people who assist with two or more activities of daily living. instrumental activities of daily living (ADLs/Instrumental activities of daily living (IADLs))of individuals with dual sensory impairment (DSI) among a clinical LVR population in older adults (≥60 years) with English proficiency free from moderate to severe depression or cognitive decline using the Zarit Burden Interview questionnaire and qualitative interview data analyses.
Aim 3 To determine feasibility and benefit of a pilot manualized over-the-counter hearing intervention program on LVR patients to address communication among a DSI population using the Zarit Burden Interview questionnaire.
3A: Describe feasibility based on completion of pilot, drop-out rate, and semi-structured interviews 3B: Describe perceived communication improvements based on semi-structured interviews
Detailed description
The pilot is a prospective cohort study. Approximately 100 participants and their identified people who assist with two or more ADLs/IADLs will be assessed for DSI prevalence and DSI impact on communication. A sub-cohort of 10 participants with DSI will be provided a hearing intervention and followed for 4-6 weeks to assess the over-the-counter hearing intervention program's impact on communication among a DSI population and its identified people who assist with two or more ADLs/IADLs.
Recruitment will be based at the Wilmer Eye Institute (East Baltimore location) LVR clinic. Recruitment efforts will focus on older adults (≥60 years) with English proficiency attending the LVR clinic. Caregivers will be identified based on self-report assistance with at least two ADLs and/or IADLs.
The hearing intervention, for the sub-cohort of 10 individuals with DSI and their identified people who assist with two or more ADLs/IADLs, consists of instruction and best-practices provided by an occupational therapist on the utilization of a handheld amplifier (SuperEar SE9000). Prior to the LVR session with the handheld amplifier, individuals with DSI will complete a daily functioning (ADLs/IADLs) questionnaire (a measure of LVR success). The occupational therapist will give participant a handheld amplifier (SuperEar SE9000) and provide instruction on device use and best-practices (i.e. reducing background noise) to improve communication for the patient-caregiver pairs.
Participant-caregiver pairs will utilize the device and communication strategies over a 4-6-week period between LVR visits. Upon return, pairs will complete semi-structured interviews to elicit information about utilization (successes, barriers), impact on communication, and open qualitative feedback. Participants and caregivers will complete post-intervention functioning questionnaire and Zarit Burden Interview, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Older Adult Participants and Informal/Formal Caregiver Pairs | – | Device: SuperEar9000A sub-cohort of approximately 10 participant-caregiver pairs will utilize SE9000 and communication strategies over a 4-6-week period between LVR visits. |
| Older Adult Participants | – | –The pilot cohort of approximately 100 adults over age 60, with vision impairment, will complete the Hearing Handicap Inventory for the Elderly (HHIE), an assessment of perceived impact of hearing impairment, and an objective hearing evaluation. |
| Formal/Informal Caregivers | – | –Identified persons who assist willing and eligible older adult pilot participants with two or more ADLs/IADLs. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aim 1 and Aim 2: 100 participants (convenience sample) and their identified people who assist with two or more ADLs/IADLs recruited from Wilmer Eye Institute's LVR clinic Aim 3: sub-cohort of 10 participants with dual sensory impairment and their identified people who assist with two or more ADLs/IADLs
Key inclusion criteria (13 listed)
- To be eligible for aims 1 \& 2 of the study, older adult participants must meet all of the following criteria:
- Age over 60 years. Individuals aged over 60 years at the time of recruitment are eligible for participation.
- Low Vision Rehab Patient/Attendee
- Fluent English Speaker
- Caregiver who reports aiding in 2 or More ADLs/IADLs.
Key exclusion criteria (10 listed)
- Potential candidates for enrollment who meet one or more of the following criteria are excluded from participation in the study:
- Medical contraindication to use handheld amplifier. Because hearing amplifier will be the primary device used in the hearing intervention, participants with medical contraindications to hearing amplifier use are excluded. Contraindication will be determined by pilot audiologist. These may include:
- Active ear infection
- Atresia
- Profound hearing loss beyond the limits of the device
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 |
|---|---|---|
| SuperEar9000Handheld hearing amplifier, not FDA regulated. | Device | Older Adult Participants and Informal/Formal Caregiver Pairs |
Primary outcome
Prevalence of Dual Sensory Impairment
Time frame: 1 day
Measured by the Hearing Handicap Inventory for the Elderly (HHIE), an assessment of perceived impact of hearing impairment, and an objective hearing evaluation (by pure tone audiometry a four-frequency test in both ears. Hearing impairment score >25dB in better ear). Total HHIE score: summation of 10 items (0, 2 or 4 points per item, total score range 0 to 40). 0-8 = no handicap; 10-24 = mild to moderate handicap; 26-40 = severe handicap.
3 secondary outcomes
Impact of Dual Sensory Impairment on Formal/informal Caregivers by 12 Question Zarit Burden Interview Questionnaire (Range 0-48, 0-10 mild burden, 10-20 mild to moderate burden, >20 high burden)
Time frame: 1 day
Feasibility of Handheld Amplifier on Communication with Formal/Informal Caregivers as assessed by Semi Structured Interviews
Time frame: 4-6 Weeks
Impact of Handheld Amplifier on Caregiver Burden with Formal/Informal Caregivers as assessed by Zarit Burden Interview Questionnaire
Time frame: 4-6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Dual Sensory Impairment of Vision and Hearing
Not yet recruiting
SENSE-Brain Health Pro for Older Adults With Sensory Loss
Vision and Hearing Loss, Vision Impairment
Not yet recruitingObservational study
Survey of Sensory Impairment Indicators Among Adults Aged 65 Years and Older in Xinxing County
Visual Impairment, Hearing Loss
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.
Nick Reed, AuD principal investigator
Johns Hopkins Bloomberg School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dual Sensory Impairment of Vision and Hearing, 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 13 inclusion and 10 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: finished, as of the sponsor's last update on 2 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of Dual Sensory Impairment (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2019.