Trial Outcomes & Findings for Educational Program for Hearing Aid Users With Internet Support (NCT NCT01837550)
NCT ID: NCT01837550
Last Updated: 2016-04-25
Results Overview
The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
5 weeks, 6 months
Results posted on
2016-04-25
Participant Flow
2013-2014; Borås Hospital, Sweden; Alingsås Hospital, Sweden; Skene Hospital, Sweden.
Participants who registered at the website and completed the screening form (n=108) were called for an interview to assess their eligibility; 104 informed an agreement to participate in the study. 14 of them did not fulfill the criteria for the Hearing Handicap Inventory for the Elderly, and 16 chose not to fill out the requested questionnaires.
Participant milestones
| Measure |
Intervention Group
Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
|
Control Group
no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content.
|
|---|---|---|
|
T0-T1, 5 Weeks
STARTED
|
37
|
37
|
|
T0-T1, 5 Weeks
COMPLETED
|
37
|
37
|
|
T0-T1, 5 Weeks
NOT COMPLETED
|
0
|
0
|
|
T0-T2, 6 Months Follow-up
STARTED
|
37
|
37
|
|
T0-T2, 6 Months Follow-up
COMPLETED
|
37
|
37
|
|
T0-T2, 6 Months Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Educational Program for Hearing Aid Users With Internet Support
Baseline characteristics by cohort
| Measure |
Intervention Group
n=37 Participants
Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
|
Control Group
n=37 Participants
no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Pure-tone average
Right ear
|
37.5 decibel Hearing Level
STANDARD_DEVIATION 11.3 • n=5 Participants
|
38.0 decibel Hearing Level
STANDARD_DEVIATION 8.6 • n=7 Participants
|
37.8 decibel Hearing Level
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Pure-tone average
Left ear
|
37.8 decibel Hearing Level
STANDARD_DEVIATION 10.5 • n=5 Participants
|
36.5 decibel Hearing Level
STANDARD_DEVIATION 8.5 • n=7 Participants
|
37.1 decibel Hearing Level
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Number of Hearing Aids
Binaurally
|
28 numbers
n=5 Participants
|
31 numbers
n=7 Participants
|
59 numbers
n=5 Participants
|
|
Number of Hearing Aids
Monaurally
|
9 numbers
n=5 Participants
|
6 numbers
n=7 Participants
|
15 numbers
n=5 Participants
|
|
Use of hearing aid
|
7.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
7.4 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
7.5 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 weeks, 6 monthsThe HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.
Outcome measures
| Measure |
Intervention Group
n=37 Participants
Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
|
Control Group
n=37 Participants
no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content.
|
|---|---|---|
|
The Hearing Handicap Inventory for the Elderly (HHIE)
Pre-measurement
|
42.0 units on a scale
Standard Deviation 16.9
|
36.1 units on a scale
Standard Deviation 11.8
|
|
The Hearing Handicap Inventory for the Elderly (HHIE)
Directly after-measurement (5 weeks)
|
35.8 units on a scale
Standard Deviation 15.2
|
31.3 units on a scale
Standard Deviation 14.3
|
|
The Hearing Handicap Inventory for the Elderly (HHIE)
6 months-post measurement
|
36.0 units on a scale
Standard Deviation 15.8
|
34.0 units on a scale
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: pre-measurementPopulation: The IOI-HA was used only at the pre-masurement point, to select descriptive data about the participants.
The IOI-HA measures hearing aid outcomes. The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life. Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.
Outcome measures
| Measure |
Intervention Group
n=37 Participants
Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
|
Control Group
n=37 Participants
no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content.
|
|---|---|---|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
1. Daily use
|
4.1 units on a scale
Standard Deviation 1.1
|
4.4 units on a scale
Standard Deviation 1.0
|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
2. Benefit
|
3.8 units on a scale
Standard Deviation 0.9
|
4.1 units on a scale
Standard Deviation 0.9
|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
3. Remaining activity limitation
|
3.1 units on a scale
Standard Deviation 0.8
|
3.1 units on a scale
Standard Deviation 0.8
|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
4. Satisfaction
|
4.1 units on a scale
Standard Deviation 1.1
|
4.4 units on a scale
Standard Deviation 0.8
|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
5. Remaining participation restriction
|
3.8 units on a scale
Standard Deviation 1.1
|
4.1 units on a scale
Standard Deviation 0.8
|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
6. Impact on environment
|
3.6 units on a scale
Standard Deviation 0.9
|
3.9 units on a scale
Standard Deviation 0.9
|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
7. Quality of life
|
3.6 units on a scale
Standard Deviation 0.8
|
3.6 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 5 weeks, 6 monthsThe HADS contains 14 items. Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.
Outcome measures
| Measure |
Intervention Group
n=37 Participants
Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
|
Control Group
n=37 Participants
no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Pre-measurement
|
8.5 units on a scale
Standard Deviation 6.6
|
7.4 units on a scale
Standard Deviation 4.8
|
|
Hospital Anxiety and Depression Scale (HADS)
Directly after-measurement (5 weeks)
|
7.5 units on a scale
Standard Deviation 6.3
|
6.5 units on a scale
Standard Deviation 5.2
|
|
Hospital Anxiety and Depression Scale (HADS)
6 months post-measurement
|
4.8 units on a scale
Standard Deviation 4.5
|
6.8 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 5 weeks, 6 monthsCSS is designed to analyze participants' behavior in various communication situations. Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125.
Outcome measures
| Measure |
Intervention Group
n=37 Participants
Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
|
Control Group
n=37 Participants
no professional support
Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content.
|
|---|---|---|
|
Communication Strategies Scale (CSS)
Pre-measurement
|
68.1 units on a scale
Standard Deviation 13.6
|
67.2 units on a scale
Standard Deviation 11.3
|
|
Communication Strategies Scale (CSS)
Directly after-measurement (5 weeks)
|
74.7 units on a scale
Standard Deviation 11.1
|
68.5 units on a scale
Standard Deviation 12.4
|
|
Communication Strategies Scale (CSS)
6 months post-measurement
|
70.9 units on a scale
Standard Deviation 10.5
|
66.7 units on a scale
Standard Deviation 11.6
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Milijana Malmberg, PhD student
Sodra Alvsborg, Hearing Organisation
Phone: 0046 703 80 36 63
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place