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A Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742609
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Noor Afzarini Hasnita Binti Ismail, University of Manchester

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE January 29, 2018
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
Hearing aid use [ Time Frame: 6-weeks ]
Self-reported hearing aid use
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2018)
  • Hearing aid use [ Time Frame: 6 weeks follow-up ]
    Data logging of hearing aid (average hour/day)
  • Hearing Aid use [ Time Frame: 6 weeks follow-up ]
    International Outcome Inventory for Hearing Aids (IOI-HA) questionnaire (7 questions with Scale 1-5/ question)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit
Official Title  ICMJE A Randomised Controlled Trial of a Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit.
Brief Summary The aim of the present study is to test I-PLAN as a self-management tool to promote hearing aid use and benefit (measured by self-reported questionnaires and hearing aid data-logging) among new adult hearing aid patients via a randomised controlled trial compared to treatment as usual. We hypothesized that the I-PLAN will increase hearing aid use and reduce self-reported hearing difficulty via promoting hearing aid use habits and self-regulation with respect to hearing aid use.
Detailed Description The aim of the present study is to test I-PLAN, an intervention designed to promote hearing aid use among adult hearing aid patients, for the first time. I-PLAN is the first intervention in audiology that has been developed using the behaviour change wheel. It consists of three components; i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Written Information
  • Written Info and Hearing Aid Reminder
  • Written Info and Planning on Hearing Aid Use
  • All Materials
Intervention  ICMJE
  • Other: ii) the reminder
    Participants assigned to the prompt group were received instruction to use their hearing aid box as a physical prompt to remind participants to use their hearing aid(s)
  • Other: ii) written behavioural plan
    Participants assigned to this group were received instruction to create at least one written plan for hearing aid use. Specifically, participants were asked to plan where and when to use their hearing aid(s).
  • Other: iv) all materials
    i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.
Study Arms  ICMJE
  • No Intervention: Information only
    provision of written information regarding consequences of using a hearing aid and not using a hearing. For example using a hearing aid will improve ability to hear others.
  • Active Comparator: Physical reminder only
    provision of written information regarding consequences of using a hearing aid and not using a hearing and physical reminder to use a hearing aid. For example, a hearing aid box as a physical reminder to use the hearing aids.
    Intervention: Other: ii) the reminder
  • Active Comparator: Behaviour Plan only
    provision of written information regarding consequences of using a hearing aid and not using a hearing and creation of behaviour plan to use a hearing aid. For example, when and where to use the hearing aids.
    Intervention: Other: ii) written behavioural plan
  • Experimental: Info, Reminder and Plan
    provision of written information regarding consequences of using a hearing aid and not using a hearing, physical reminder and creation of behaviour plan to use a hearing aid
    Intervention: Other: iv) all materials
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2018
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 18 years old or above
  2. Have never used a hearing aid before
  3. Have good understanding of English
  4. have sufficient mental capacity to provide informal consent based on audiologist's opinion

Exclusion Criteria:

  1. Have inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
  2. presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA, 2007)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03742609
Other Study ID Numbers  ICMJE 234737
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Noor Afzarini Hasnita Binti Ismail, University of Manchester
Study Sponsor  ICMJE University of Manchester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Piers Dawes, Dr Manchester Centre for Audiology and Deafness,University of Manchester
PRS Account University of Manchester
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP