Trial Outcomes & Findings for A Mobile Personal Health Record for Behavioral Health Homes (NCT NCT01890226)
NCT ID: NCT01890226
Last Updated: 2020-02-17
Results Overview
It is a measure of quality of care. The aggregate score represents the total number of eligible services received for an individual generated by dividing all instances in which recommended care was delivered by the number of times a participant was eligible for the indicator. The score ranges from 0 to 1 with higher scores indicating receipt of recommended care/services.
COMPLETED
NA
311 participants
Baseline, 12 month post intervention
2020-02-17
Participant Flow
311 participants were eligible and consented to participate.
Participant milestones
| Measure |
Control
Control or usual care group: had access to the full array o services offered through the behavioral health homes.
|
Experimental: Intervention
Participants randomized to the intervention arm will receive the mobile personal health record.
Mobile Personal Health Record App.
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
156
|
|
Overall Study
COMPLETED
|
155
|
156
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Mobile Personal Health Record for Behavioral Health Homes
Baseline characteristics by cohort
| Measure |
Control
n=155 Participants
Control or usual care group: had access to the full array of services offered through the behavioral health homes.
|
Experimental: Intervention
n=156 Participants
Participants randomized to the intervention arm will receive the mobile personal health record.
Mobile Personal Health Record App.
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.54 years
STANDARD_DEVIATION 9.08 • n=99 Participants
|
50.78 years
STANDARD_DEVIATION 8.45 • n=107 Participants
|
50.66 years
STANDARD_DEVIATION 8.76 • n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
123 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
241 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=99 Participants
|
156 participants
n=107 Participants
|
311 participants
n=206 Participants
|
|
total annual income
$0-$5,000
|
83 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
|
total annual income
$5,000-$10,000
|
43 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
total annual income
$10,000-$15,000
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
total annual income
More than $15,000
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
total annual income
Did not answer
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Medical Diagnosis
Diabetes
|
68 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Medical Diagnosis
Heart Disease/CAD/CHD
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Medical Diagnosis
Hyperlipidemia
|
70 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Medical Diagnosis
Hypertension
|
123 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
257 Participants
n=206 Participants
|
|
Mental Diagnosis
Schizophrenia
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Mental Diagnosis
Bipolar Disorder
|
41 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Mental Diagnosis
Depression
|
122 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
|
Mental Diagnosis
Obsessive Compulsive Disorder
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Mental Diagnosis
Post-Traumatic stress Disorder
|
26 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 month post interventionPopulation: Chart review data, which were used to assess overall quality of care, were available for all participants at baseline and 12-month follow-up.
It is a measure of quality of care. The aggregate score represents the total number of eligible services received for an individual generated by dividing all instances in which recommended care was delivered by the number of times a participant was eligible for the indicator. The score ranges from 0 to 1 with higher scores indicating receipt of recommended care/services.
Outcome measures
| Measure |
Control
n=155 Participants
Control or usual care group: had access to the full array o services offered through the behavioral health homes.
|
Experimental: Intervention
n=156 Participants
Participants randomized to the intervention arm will receive the mobile personal health record.
Mobile Personal Health Record App.
|
|---|---|---|
|
Change in Composite Quality Score
Baseline
|
0.71 score on a scale
Standard Deviation 0.12
|
0.70 score on a scale
Standard Deviation 0.11
|
|
Change in Composite Quality Score
12-month post-baseline
|
0.67 score on a scale
Standard Deviation 0.16
|
0.70 score on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline, 6 month post intervention, 12 month post interventionPopulation: Completion rates for patient interviews were 91.9% at 6-months and 84.6% for 12 months, with similar rates of attrition in both groups.
20-item patient self-report instrument that assesses the extent to which patients with chronic illness report receiving care that aligns with the Chronic Care Model. The summary score ranges from 1 to 5 with a higher score indicating patient's perception of greater involvement in self-management and receipt of chronic care counseling.
Outcome measures
| Measure |
Control
n=155 Participants
Control or usual care group: had access to the full array o services offered through the behavioral health homes.
|
Experimental: Intervention
n=156 Participants
Participants randomized to the intervention arm will receive the mobile personal health record.
Mobile Personal Health Record App.
|
|---|---|---|
|
Change in Patient Assessment of Chronic Illness Care
Baseline
|
3.23 score on a scale
Standard Deviation 1.00
|
3.20 score on a scale
Standard Deviation 0.95
|
|
Change in Patient Assessment of Chronic Illness Care
6-month post-baseline
|
3.32 score on a scale
Standard Deviation 1.01
|
3.32 score on a scale
Standard Deviation 0.93
|
|
Change in Patient Assessment of Chronic Illness Care
12-month post-baseline
|
3.18 score on a scale
Standard Deviation 0.95
|
3.25 score on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Baseline, 6 month post intervention, 12 month post interventionPopulation: Completion rates for patient interviews were 91.9% at 6-months and 84.6% for 12 months, with similar rates of attrition in both groups.
Assesses a patients' perceived ability to manage their illnesses and their healthcare visits. Patient Activation Measure Scores were summed to calculate the overall raw score then transformed to an activation scale ranging from 0 to 100. Higher scores indicate greater patient activation.
Outcome measures
| Measure |
Control
n=155 Participants
Control or usual care group: had access to the full array o services offered through the behavioral health homes.
|
Experimental: Intervention
n=156 Participants
Participants randomized to the intervention arm will receive the mobile personal health record.
Mobile Personal Health Record App.
|
|---|---|---|
|
Change in Patient Activation Measure
Baseline
|
57.83 score on a scale
Standard Deviation 13.65
|
58.78 score on a scale
Standard Deviation 14.65
|
|
Change in Patient Activation Measure
6-month post-baseline
|
60.88 score on a scale
Standard Deviation 15.18
|
59.82 score on a scale
Standard Deviation 15.89
|
|
Change in Patient Activation Measure
12-month post-baseline
|
32.08 score on a scale
Standard Deviation 14.77
|
61.61 score on a scale
Standard Deviation 16.19
|
SECONDARY outcome
Timeframe: Baseline, 6 month post intervention, 12 month post interventionPopulation: Completion rates for patient interviews were 91.9% at 6-months and 84.6% for 12 months, with similar rates of attrition in both groups.
Measured using the Physical and Mental Component Summary scales of the SF-12. Assesses a patients' perceived health related quality of life. The composite physical (PCS) and mental component (MCS) summary scores for the SF-12 are each scored on a 0-100 scale. Higher scores indicate better functioning.
Outcome measures
| Measure |
Control
n=150 Participants
Control or usual care group: had access to the full array o services offered through the behavioral health homes.
|
Experimental: Intervention
n=147 Participants
Participants randomized to the intervention arm will receive the mobile personal health record.
Mobile Personal Health Record App.
|
|---|---|---|
|
Change in Health-related Quality of Life
SF-12 PCS Baseline
|
35.70 score on a scale
Standard Deviation 11.62
|
35.74 score on a scale
Standard Deviation 11.83
|
|
Change in Health-related Quality of Life
SF-12 PCS 6-month
|
36.32 score on a scale
Standard Deviation 11.52
|
37.20 score on a scale
Standard Deviation 11.94
|
|
Change in Health-related Quality of Life
SF-12 PCS 12-month
|
36.09 score on a scale
Standard Deviation 11.75
|
37.03 score on a scale
Standard Deviation 12.15
|
|
Change in Health-related Quality of Life
SF-12 MCS Baseline
|
36.55 score on a scale
Standard Deviation 13.25
|
35.50 score on a scale
Standard Deviation 12.54
|
|
Change in Health-related Quality of Life
SF-12 MCS 6-month
|
38.70 score on a scale
Standard Deviation 13.18
|
39.16 score on a scale
Standard Deviation 13.48
|
|
Change in Health-related Quality of Life
SF-12 MCS 12-month
|
41.16 score on a scale
Standard Deviation 11.61
|
41.68 score on a scale
Standard Deviation 14.04
|
Adverse Events
Control
Experimental: Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place