Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dual Sensory Impairment Low Vision Rehabilitation (LVR) Initiative (LVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664349
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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. 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


Condition or disease Intervention/treatment
Dual Sensory Impairment of Vision and Hearing Device: SuperEar9000

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: SuperEar9000
Handheld hearing amplifier, not FDA regulated.

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.



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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 ]

    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

  2. Feasibility of Handheld Amplifier on Communication with Formal/Informal Caregivers as assessed by Semi Structured Interviews [ Time Frame: 4-6 Weeks ]
    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.

  3. Impact of Handheld Amplifier on Caregiver Burden with Formal/Informal Caregivers as assessed by Zarit Burden Interview Questionnaire [ Time Frame: 4-6 Weeks ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria- Older Adult Participants

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
  • 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.

Exclusion Criteria:

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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664349


Contacts
Layout table for location contacts
Contact: Nick Reed, AuD 4105024332 nreed9@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Low Vision Rehabilitation Clinic, Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Nicholas S Reed, Aud.    410-502-4331    reedresearchteam@gmail.com   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Nick Reed, AuD Johns Hopkins Bloomberg School of Medicine

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03664349     History of Changes
Other Study ID Numbers: IRB00183648
LVR-F-1 ( Other Identifier: Other )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Vision, Low
Hypesthesia
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Somatosensory Disorders