Trial Outcomes & Findings for Hearing for Communication and Resident Engagement (NCT NCT04575051)

Last Updated: 2024-12-13

Results Overview

PROMIS Satisfaction with Participation in Discretionary Social Activities SF7a self-reported contentment with leisure interests and relationships with friends. T- scores are provided ranging from 27 to 65.6 where higher scores indicate more satisfaction (50 indicates the population mean with a standard deviation of 10).

Recruitment status

COMPLETED

Study phase

Target enrollment

684 participants

Primary outcome timeframe

Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months

Results posted on

2024-12-13

Participant Flow

The study was an open cohort stepped wedge design with continuous recruitment and enrollment. Residents were enrolled at Time Period 0 but could be enrolled at any time period of the study due to being a new resident of the facility or being interested at the time period they were approached. The protocol enrollment reflects the total number enrolled at all 10 facilities across 6 time points (Time Periods 0-5).

Available family members of residents in the study and staff in the facilities were asked to complete surveys for the secondary outcomes during each data collection period. These individuals were not tracked across time periods or documented for lost-to-follow-up or discontinuation from the study. The number of surveys and the corresponding results are presented in the secondary outcomes. No adverse event data were required to be collected for family members and staff.

Unit of analysis: residential facility

Participant milestones

Participant milestones
Measure	Group 1 (HearCARE Start at T1) Facilities had the Consult Model for Time Period 0 then started the HearCARE program at Time Period 1 and continued with the HearCARE program through Time Period 5.	Group 2 (HearCARE Start at T2) Facilities had the Consult Model for Time Periods 0 and 1 then started the HearCARE program at Time Period 2 and continued with the HearCARE program through Time Period 5.	Group 3 (HearCARE Start at T3) Facilities had the Consult Model for Time Periods 0, 1 and 2 then started the HearCARE program at Time Period 3 and continued with the HearCARE program through Time Period 5.	Group 4 (HearCARE Start at T4) Facilities had the Consult Model for Time Periods 0, 1, 2, and 3 then started the HearCARE program at Time Period 4 and continued with the HearCARE program through Time Period 5.	Group 5 (HearCARE Start at T5) Facilities had the Consult Model for Time Periods 0-4 then started the HearCARE program at Time Period 5.
Time Period 0 STARTED	62 2	55 2	87 2	77 2	44 2
Time Period 0 COMPLETED	47 2	49 2	68 2	68 2	36 2
Time Period 0 NOT COMPLETED	15 0	6 0	19 0	9 0	8 0
Time Period 1 STARTED	69 2	84 2	89 2	87 2	58 2
Time Period 1 COMPLETED	55 2	67 2	79 2	69 2	42 2
Time Period 1 NOT COMPLETED	14 0	17 0	10 0	18 0	16 0
Time Period 2 STARTED	75 2	75 2	99 2	80 2	51 2
Time Period 2 COMPLETED	59 2	59 2	72 2	65 2	42 2
Time Period 2 NOT COMPLETED	16 0	16 0	27 0	15 0	9 0
Time Period 3 STARTED	87 2	82 2	96 2	65 2	56 2
Time Period 3 COMPLETED	74 2	72 2	81 2	59 2	53 2
Time Period 3 NOT COMPLETED	13 0	10 0	15 0	6 0	3 0
Time Period 4 STARTED	96 2	92 2	100 2	70 2	62 2
Time Period 4 COMPLETED	77 2	86 2	87 2	67 2	52 2
Time Period 4 NOT COMPLETED	19 0	6 0	13 0	3 0	10 0
Time Period 5 STARTED	112 2	98 2	97 2	80 2	59 2
Time Period 5 COMPLETED	101 2	90 2	85 2	77 2	48 2
Time Period 5 NOT COMPLETED	11 0	8 0	12 0	3 0	11 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 (HearCARE Start at T1) Facilities had the Consult Model for Time Period 0 then started the HearCARE program at Time Period 1 and continued with the HearCARE program through Time Period 5.	Group 2 (HearCARE Start at T2) Facilities had the Consult Model for Time Periods 0 and 1 then started the HearCARE program at Time Period 2 and continued with the HearCARE program through Time Period 5.	Group 3 (HearCARE Start at T3) Facilities had the Consult Model for Time Periods 0, 1 and 2 then started the HearCARE program at Time Period 3 and continued with the HearCARE program through Time Period 5.	Group 4 (HearCARE Start at T4) Facilities had the Consult Model for Time Periods 0, 1, 2, and 3 then started the HearCARE program at Time Period 4 and continued with the HearCARE program through Time Period 5.	Group 5 (HearCARE Start at T5) Facilities had the Consult Model for Time Periods 0-4 then started the HearCARE program at Time Period 5.
Time Period 0 Discontinued due to death or moving to higher level of care	15	6	19	9	8
Time Period 1 Missing follow up	1	3	1	3	2
Time Period 1 Discontinued due to death or moving to higher level of care	13	14	9	15	14
Time Period 2 Missing follow up	1	8	7	0	1
Time Period 2 Discontinued due to death or moved to higher level of care	15	8	20	15	8
Time Period 3 Missing follow up	8	6	4	3	0
Time Period 3 Discontinued due to death or moved to higher level of care	5	4	11	3	3
Time Period 4 Missing follow up	17	3	4	2	1
Time Period 4 Discontinued due to death or moved to higher level of care	2	3	9	1	9
Time Period 5 Missing follow up	11	8	12	3	11

Baseline Characteristics

Analysis for those with information on age. Some participants did not complete this information.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (HearCARE Start T1) n=162 Participants Participants in these facilities had the Consult Model for Time Period 0 then started the HearCARE program at Time Period 1 and continued with the HearCARE program through Time Period 5.	Group 2 (HearCARE Start T2) n=133 Participants Participants in these facilities had the Consult Model for Time Periods 0 and 1 then started the HearCARE program at Time Period 2 and continued with the HearCARE program through Time Period 5.	Group 3 (HearCARE Start T3) n=165 Participants Participants in these facilities had the Consult Model for Time Periods 0, 1 and 2 then started the HearCARE program at Time Period 3 and continued with the HearCARE program through Time Period 5.	Group 4 (HearCARE Start T4) n=123 Participants Participants in these facilities had the Consult Model for Time Periods 0, 1, 2, and 3 then started the HearCARE program at Time Period 4 and continued with the HearCARE program through Time Period 5.	Group 5 (HearCARE Start T5) n=101 Participants Participants in these facilities had the Consult Model for Time Periods 0-4 then started the HearCARE program at Time Period 5.	Total n=684 Participants Total of all reporting groups
Age, Continuous	89.3 years STANDARD_DEVIATION 7.8 • n=147 Participants • Analysis for those with information on age. Some participants did not complete this information.	87.8 years STANDARD_DEVIATION 7.1 • n=106 Participants • Analysis for those with information on age. Some participants did not complete this information.	87.3 years STANDARD_DEVIATION 8.3 • n=151 Participants • Analysis for those with information on age. Some participants did not complete this information.	89.0 years STANDARD_DEVIATION 8.4 • n=110 Participants • Analysis for those with information on age. Some participants did not complete this information.	83.8 years STANDARD_DEVIATION 8.6 • n=86 Participants • Analysis for those with information on age. Some participants did not complete this information.	87.7 years STANDARD_DEVIATION 8.2 • n=600 Participants • Analysis for those with information on age. Some participants did not complete this information.
Sex: Female, Male Female	123 Participants n=162 Participants	96 Participants n=133 Participants	126 Participants n=165 Participants	89 Participants n=123 Participants	61 Participants n=101 Participants	495 Participants n=684 Participants
Sex: Female, Male Male	39 Participants n=162 Participants	37 Participants n=133 Participants	39 Participants n=165 Participants	34 Participants n=123 Participants	40 Participants n=101 Participants	189 Participants n=684 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=162 Participants	0 Participants n=133 Participants	0 Participants n=165 Participants	0 Participants n=123 Participants	0 Participants n=101 Participants	1 Participants n=684 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	161 Participants n=162 Participants	133 Participants n=133 Participants	165 Participants n=165 Participants	123 Participants n=123 Participants	101 Participants n=101 Participants	683 Participants n=684 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=162 Participants	0 Participants n=133 Participants	0 Participants n=165 Participants	0 Participants n=123 Participants	0 Participants n=101 Participants	0 Participants n=684 Participants
Race/Ethnicity, Customized White	155 participants n=162 Participants	120 participants n=133 Participants	160 participants n=165 Participants	116 participants n=123 Participants	92 participants n=101 Participants	643 participants n=684 Participants
Race/Ethnicity, Customized Not White	4 participants n=162 Participants	6 participants n=133 Participants	3 participants n=165 Participants	2 participants n=123 Participants	0 participants n=101 Participants	15 participants n=684 Participants
Race/Ethnicity, Customized Not Reported	3 participants n=162 Participants	7 participants n=133 Participants	2 participants n=165 Participants	5 participants n=123 Participants	9 participants n=101 Participants	26 participants n=684 Participants
Region of Enrollment United States	162 participants n=162 Participants	133 participants n=133 Participants	165 participants n=165 Participants	123 participants n=123 Participants	101 participants n=101 Participants	684 participants n=684 Participants
Hearing Handicap Inventory at Enrollment	8.2 units on a scale STANDARD_DEVIATION 9.2 • n=159 Participants • Analysis among those with survey information. Some participants did not complete the survey.	9.0 units on a scale STANDARD_DEVIATION 9.0 • n=131 Participants • Analysis among those with survey information. Some participants did not complete the survey.	8.6 units on a scale STANDARD_DEVIATION 8.9 • n=162 Participants • Analysis among those with survey information. Some participants did not complete the survey.	8.0 units on a scale STANDARD_DEVIATION 9.5 • n=115 Participants • Analysis among those with survey information. Some participants did not complete the survey.	6.5 units on a scale STANDARD_DEVIATION 8.4 • n=98 Participants • Analysis among those with survey information. Some participants did not complete the survey.	8.2 units on a scale STANDARD_DEVIATION 9.0 • n=665 Participants • Analysis among those with survey information. Some participants did not complete the survey.
PROMIS Participation at Enrollment	49.4 T-score STANDARD_DEVIATION 7.1 • n=151 Participants • Analysis of those with survey data. Some participants did not complete the survey.	50.6 T-score STANDARD_DEVIATION 8.1 • n=117 Participants • Analysis of those with survey data. Some participants did not complete the survey.	49.9 T-score STANDARD_DEVIATION 8.8 • n=159 Participants • Analysis of those with survey data. Some participants did not complete the survey.	48.1 T-score STANDARD_DEVIATION 7.2 • n=113 Participants • Analysis of those with survey data. Some participants did not complete the survey.	49.8 T-score STANDARD_DEVIATION 7.3 • n=98 Participants • Analysis of those with survey data. Some participants did not complete the survey.	49.6 T-score STANDARD_DEVIATION 7.8 • n=638 Participants • Analysis of those with survey data. Some participants did not complete the survey.
Pure tone average right side	43.5 decibels STANDARD_DEVIATION 14.2 • n=121 Participants • Analysis conducted for participants with hearing assessments.	47.0 decibels STANDARD_DEVIATION 15.8 • n=69 Participants • Analysis conducted for participants with hearing assessments.	44.1 decibels STANDARD_DEVIATION 17.5 • n=117 Participants • Analysis conducted for participants with hearing assessments.	47.6 decibels STANDARD_DEVIATION 17.0 • n=64 Participants • Analysis conducted for participants with hearing assessments.	39.5 decibels STANDARD_DEVIATION 14.0 • n=83 Participants • Analysis conducted for participants with hearing assessments.	44.0 decibels STANDARD_DEVIATION 15.9 • n=454 Participants • Analysis conducted for participants with hearing assessments.
Pure tone average left side	43.6 decibels STANDARD_DEVIATION 14.8 • n=122 Participants • Analysis among those with hearing assessments.	47.3 decibels STANDARD_DEVIATION 15.8 • n=70 Participants • Analysis among those with hearing assessments.	44.1 decibels STANDARD_DEVIATION 17.0 • n=115 Participants • Analysis among those with hearing assessments.	47.0 decibels STANDARD_DEVIATION 14.9 • n=63 Participants • Analysis among those with hearing assessments.	40.7 decibels STANDARD_DEVIATION 14.3 • n=83 Participants • Analysis among those with hearing assessments.	44.3 decibels STANDARD_DEVIATION 15.6 • n=453 Participants • Analysis among those with hearing assessments.

PRIMARY outcome

Timeframe: Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months

Population: The overall number of participants analyzed represents the number of unique participants who provided data across the time points. The number at each time point represents the number of participants who contributed survey data at that time point. Due to the open cohort nature of the trial, the number with survey data represents both those enrolled who did not leave the cohort and those with survey data entering the cohort (newly enrolled).

Outcome measures

Outcome measures
Measure	Group 1 (HearCARE Start at T1) n=162 Participants Facilities had the Consult Model for Time Period 0 then started the HearCARE program at Time Period 1 and continued with the HearCARE program through Time Period 5.	Group 2 (HearCARE Start at T2) n=133 Participants Facilities had the Consult Model for Time Periods 0 and 1 then started the HearCARE program at Time Period 2 and continued with the HearCARE program through Time Period 5.	Group 3 (HearCARE Start at T3) n=165 Participants Facilities had the Consult Model for Time Periods 0, 1 and 2 then started the HearCARE program at Time Period 3 and continued with the HearCARE program through Time Period 5.	Group 4 (HearCARE Start at T4) n=123 Participants Facilities had the Consult Model for Time Periods 0, 1, 2, and 3 then started the HearCARE program at Time Period 4 and continued with the HearCARE program through Time Period 5.	Group 5 (HearCARE Start at T5) n=101 Participants Facilities had the Consult Model for Time Periods 0-4 then started the HearCARE program at Time Period 5.
Satisfaction With Social Participation Baseline (Time 0)	49.7 T-score Standard Deviation 7.9	52.8 T-score Standard Deviation 8.9	51.2 T-score Standard Deviation 10.3	49.4 T-score Standard Deviation 6.6	51.7 T-score Standard Deviation 7.6
Satisfaction With Social Participation 5 months (Time 1)	49.7 T-score Standard Deviation 7.8	48.4 T-score Standard Deviation 6.7	47.6 T-score Standard Deviation 8.7	48.1 T-score Standard Deviation 5.6	48.1 T-score Standard Deviation 7.0
Satisfaction With Social Participation 10 months (Time 2)	48.1 T-score Standard Deviation 7.1	47.6 T-score Standard Deviation 6.1	49.4 T-score Standard Deviation 7.0	48.6 T-score Standard Deviation 7.0	47.4 T-score Standard Deviation 6.0
Satisfaction With Social Participation 15 months (Time 3)	52.0 T-score Standard Deviation 7.1	47.1 T-score Standard Deviation 6.5	45.4 T-score Standard Deviation 6.2	49.9 T-score Standard Deviation 8.1	48.4 T-score Standard Deviation 6.6
Satisfaction With Social Participation 20 months (Time 4)	49.4 T-score Standard Deviation 5.6	49.0 T-score Standard Deviation 7.1	47.2 T-score Standard Deviation 6.3	48.1 T-score Standard Deviation 6.8	48.2 T-score Standard Deviation 6.4
Satisfaction With Social Participation 25 months (Time 5)	49.1 T-score Standard Deviation 7.3	48.2 T-score Standard Deviation 7.8	49.6 T-score Standard Deviation 8.2	47.4 T-score Standard Deviation 7.2	48.9 T-score Standard Deviation 6.7

PRIMARY outcome

Timeframe: Baseline, at 5, 10, 15, 20 and 25 months

Hearing Handicap Inventory for the Elderly captures social and emotional hearing handicap. 10 items with responses scored 0, 2, and 4 for 'No', 'Sometimes', and 'Yes'; min total score is 0 and maximum is 40. Higher scores indicate worse impact of hearing difficulties on activities and participation.

Outcome measures

Outcome measures
Measure	Group 1 (HearCARE Start at T1) n=162 Participants Facilities had the Consult Model for Time Period 0 then started the HearCARE program at Time Period 1 and continued with the HearCARE program through Time Period 5.	Group 2 (HearCARE Start at T2) n=133 Participants Facilities had the Consult Model for Time Periods 0 and 1 then started the HearCARE program at Time Period 2 and continued with the HearCARE program through Time Period 5.	Group 3 (HearCARE Start at T3) n=165 Participants Facilities had the Consult Model for Time Periods 0, 1 and 2 then started the HearCARE program at Time Period 3 and continued with the HearCARE program through Time Period 5.	Group 4 (HearCARE Start at T4) n=123 Participants Facilities had the Consult Model for Time Periods 0, 1, 2, and 3 then started the HearCARE program at Time Period 4 and continued with the HearCARE program through Time Period 5.	Group 5 (HearCARE Start at T5) n=101 Participants Facilities had the Consult Model for Time Periods 0-4 then started the HearCARE program at Time Period 5.
Hearing-Specific Health-Related Quality of Life Baseline (Time 0)	10.2 score on a scale Standard Deviation 11.2	10.6 score on a scale Standard Deviation 9.6	9.2 score on a scale Standard Deviation 10.2	7.5 score on a scale Standard Deviation 8.9	8.1 score on a scale Standard Deviation 9.4
Hearing-Specific Health-Related Quality of Life 5 months (Time 1)	9.4 score on a scale Standard Deviation 9.6	10.9 score on a scale Standard Deviation 10.1	9.4 score on a scale Standard Deviation 9.2	9.2 score on a scale Standard Deviation 10.9	8.9 score on a scale Standard Deviation 9.1
Hearing-Specific Health-Related Quality of Life 10 months (Time 2)	8.9 score on a scale Standard Deviation 8.8	11.6 score on a scale Standard Deviation 10.2	8.9 score on a scale Standard Deviation 8.5	9.2 score on a scale Standard Deviation 9.0	5.6 score on a scale Standard Deviation 7.0
Hearing-Specific Health-Related Quality of Life 15 months (Time 3)	7.3 score on a scale Standard Deviation 8.9	9.8 score on a scale Standard Deviation 10.0	9.5 score on a scale Standard Deviation 9.2	10.1 score on a scale Standard Deviation 9.5	6.7 score on a scale Standard Deviation 8.5
Hearing-Specific Health-Related Quality of Life 20 months (Time 4)	6.9 score on a scale Standard Deviation 8.3	8.5 score on a scale Standard Deviation 8.3	7.9 score on a scale Standard Deviation 7.7	9.7 score on a scale Standard Deviation 8.9	7.0 score on a scale Standard Deviation 8.8
Hearing-Specific Health-Related Quality of Life 25 months (Time 5)	9.0 score on a scale Standard Deviation 11.0	8.5 score on a scale Standard Deviation 10.0	4.4 score on a scale Standard Deviation 5.0	6.9 score on a scale Standard Deviation 8.5	5.6 score on a scale Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline, at 5, 10, 15, 20 and 25 months

Zarit Burden Interview is a 4-item questionnaire that measures caregiver burden. The 4 items each have responses ranging from 0='Never' to 4='Nearly Always'. Item responses are summed to produce the total score that ranges from 0 to 16 with higher scores indicating more burden.

Outcome measures

Outcome measures
Measure	Group 1 (HearCARE Start at T1) n=78 Participants Facilities had the Consult Model for Time Period 0 then started the HearCARE program at Time Period 1 and continued with the HearCARE program through Time Period 5.	Group 2 (HearCARE Start at T2) n=85 Participants Facilities had the Consult Model for Time Periods 0 and 1 then started the HearCARE program at Time Period 2 and continued with the HearCARE program through Time Period 5.	Group 3 (HearCARE Start at T3) n=116 Participants Facilities had the Consult Model for Time Periods 0, 1 and 2 then started the HearCARE program at Time Period 3 and continued with the HearCARE program through Time Period 5.	Group 4 (HearCARE Start at T4) n=83 Participants Facilities had the Consult Model for Time Periods 0, 1, 2, and 3 then started the HearCARE program at Time Period 4 and continued with the HearCARE program through Time Period 5.	Group 5 (HearCARE Start at T5) n=72 Participants Facilities had the Consult Model for Time Periods 0-4 then started the HearCARE program at Time Period 5.
Family Burden Baseline (Time 0)	5.5 score on a scale Standard Deviation 3.7	4.4 score on a scale Standard Deviation 3.4	5.4 score on a scale Standard Deviation 3.0	4.7 score on a scale Standard Deviation 3.6	4.9 score on a scale Standard Deviation 3.0
Family Burden 5 months (Time 1)	3.6 score on a scale Standard Deviation 2.8	3.9 score on a scale Standard Deviation 2.9	4.5 score on a scale Standard Deviation 3.1	4.2 score on a scale Standard Deviation 3.7	4.6 score on a scale Standard Deviation 3.4
Family Burden 10 months (Time 2)	3.9 score on a scale Standard Deviation 2.8	6.7 score on a scale Standard Deviation 4.4	5.6 score on a scale Standard Deviation 3.3	4.8 score on a scale Standard Deviation 3.7	4.8 score on a scale Standard Deviation 3.8
Family Burden 15 months (Time 3)	5.1 score on a scale Standard Deviation 3.7	5.2 score on a scale Standard Deviation 4.6	5.4 score on a scale Standard Deviation 3.0	4.1 score on a scale Standard Deviation 3.8	5.0 score on a scale Standard Deviation 4.8
Family Burden 20 months (Time 4)	4.8 score on a scale Standard Deviation 2.8	3 score on a scale Standard Deviation 2.8	5.9 score on a scale Standard Deviation 3.7	5.0 score on a scale Standard Deviation 3.5	5.3 score on a scale Standard Deviation 3.9
Family Burden 25 months (Time 5)	5.1 score on a scale Standard Deviation 2.7	4.3 score on a scale Standard Deviation 4.0	5.4 score on a scale Standard Deviation 2.8	4.6 score on a scale Standard Deviation 3.9	4.4 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: Baseline, at 5, 10, 15, 20 and 25 months

Michigan Organizational Assessment Questionnaire (MOAQ) is a 3-item questionnaire that measures satisfaction with one's job. Items have responses ranging from 1='Agree Strongly' to 6='Disagree Strongly'. The combined score is the average of the 3 items with one item reverse scored. Higher scores indicate less satisfaction.