Trial Outcomes & Findings for Adjusting to Chronic Conditions Using Education, Support, and Skills (NCT NCT01149772)
NCT ID: NCT01149772
Last Updated: 2016-02-24
Results Overview
The PHQ-9 measures an individual's level of depression. The measure is summed and ranges from 0 - 27 (individual item score range 0 - 3 per 9 items); where higher scores = worse symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
302 participants
Primary outcome timeframe
4 month (post treatment), 8 month follow/up, and 12 month follow/up
Results posted on
2016-02-24
Participant Flow
Participant milestones
| Measure |
ACCESS
Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
|
Enhanced Usual Care
Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
122
|
|
Overall Study
COMPLETED
|
132
|
101
|
|
Overall Study
NOT COMPLETED
|
48
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjusting to Chronic Conditions Using Education, Support, and Skills
Baseline characteristics by cohort
| Measure |
ACCESS
n=180 Participants
Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. After completion of the active treatment sessions, the participant will receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. Each active treatment session lasts 30 - 40 minutes and the booster calls last 10 - 15 minute.
|
Enhanced Usual Care
n=122 Participants
Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 8.8 • n=39 Participants
|
66.5 years
STANDARD_DEVIATION 8.3 • n=41 Participants
|
65.5 years
STANDARD_DEVIATION 8.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=39 Participants
|
116 Participants
n=41 Participants
|
284 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=39 Participants
|
122 participants
n=41 Participants
|
302 participants
n=35 Participants
|
|
Patient Health Questionnaire (PHQ9)
|
13.8 units on a scale
STANDARD_DEVIATION 4.6 • n=39 Participants
|
14.9 units on a scale
STANDARD_DEVIATION 5.0 • n=41 Participants
|
14.2 units on a scale
STANDARD_DEVIATION 4.8 • n=35 Participants
|
|
Beck Anxiety Inventory (BAI)
|
21.4 units on a scale
STANDARD_DEVIATION 8.9 • n=39 Participants
|
22.9 units on a scale
STANDARD_DEVIATION 10.7 • n=41 Participants
|
22.0 units on a scale
STANDARD_DEVIATION 9.6 • n=35 Participants
|
|
Chronic Respiratory Questionnaire_Mastery
|
3.63 units on a scale
STANDARD_DEVIATION 1.03 • n=39 Participants
|
3.48 units on a scale
STANDARD_DEVIATION 1.16 • n=41 Participants
|
3.57 units on a scale
STANDARD_DEVIATION 1.08 • n=35 Participants
|
|
Chronic Respiratory Questionnaire_Dyspnea
|
3.05 units on a scale
STANDARD_DEVIATION .95 • n=39 Participants
|
2.90 units on a scale
STANDARD_DEVIATION 1.03 • n=41 Participants
|
2.99 units on a scale
STANDARD_DEVIATION .98 • n=35 Participants
|
|
Chronic Respiratory Questionnaire_Fatigue
|
2.63 units on a scale
STANDARD_DEVIATION .90 • n=39 Participants
|
2.43 units on a scale
STANDARD_DEVIATION .97 • n=41 Participants
|
2.55 units on a scale
STANDARD_DEVIATION .93 • n=35 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
|
36.93 units on a scale
STANDARD_DEVIATION 14.94 • n=39 Participants
|
37.03 units on a scale
STANDARD_DEVIATION 19.36 • n=41 Participants
|
36.97 units on a scale
STANDARD_DEVIATION 16.81 • n=35 Participants
|
PRIMARY outcome
Timeframe: 4 month (post treatment), 8 month follow/up, and 12 month follow/upThe PHQ-9 measures an individual's level of depression. The measure is summed and ranges from 0 - 27 (individual item score range 0 - 3 per 9 items); where higher scores = worse symptoms.
Outcome measures
| Measure |
ACCESS
n=132 Participants
Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
|
Enhanced Usual Care
n=101 Participants
Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
|
|---|---|---|
|
Patient Health Questionnaire -9 (PHQ-9)
4 Month
|
10.35 units on a scale
Standard Deviation 5.08
|
13.28 units on a scale
Standard Deviation 5.82
|
|
Patient Health Questionnaire -9 (PHQ-9)
8 Month
|
10.32 units on a scale
Standard Deviation 5.48
|
13.49 units on a scale
Standard Deviation 6.05
|
|
Patient Health Questionnaire -9 (PHQ-9)
12 Month
|
10.59 units on a scale
Standard Deviation 5.07
|
13.22 units on a scale
Standard Deviation 6.38
|
PRIMARY outcome
Timeframe: 4 month (post treatment), 8 month follow/up, and 12 month follow/upThe BAI measures an individual's level of anxiety. The measure is summed and ranges from 0 - 63 (individual item score range 0 -3 per 21 items); were higher scores = worse symptoms.
Outcome measures
| Measure |
ACCESS
n=132 Participants
Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
|
Enhanced Usual Care
n=101 Participants
Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
|
|---|---|---|
|
Beck Anxiety Inventory (BAI)
4 Month
|
17.42 units on a scale
Standard Deviation 8.52
|
22.67 units on a scale
Standard Deviation 11.18
|
|
Beck Anxiety Inventory (BAI)
8 Month
|
16.85 units on a scale
Standard Deviation 9.27
|
21.59 units on a scale
Standard Deviation 11.41
|
|
Beck Anxiety Inventory (BAI)
12 Month
|
16.97 units on a scale
Standard Deviation 7.91
|
21.19 units on a scale
Standard Deviation 11.40
|
PRIMARY outcome
Timeframe: 4 month (post treatment), 8 month follow/up, 12 month follow/upPopulation: Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.
The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. This subscale measures the amount of fatigue patients experience with the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.
Outcome measures
| Measure |
ACCESS
n=101 Participants
Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
|
Enhanced Usual Care
n=74 Participants
Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
|
|---|---|---|
|
Chronic Respiratory Questionnaire_Fatigue
4 month
|
3.20 units on a scale
Standard Deviation 1.08
|
2.58 units on a scale
Standard Deviation 1.08
|
|
Chronic Respiratory Questionnaire_Fatigue
8 month
|
3.11 units on a scale
Standard Deviation 1.09
|
2.68 units on a scale
Standard Deviation 1.01
|
|
Chronic Respiratory Questionnaire_Fatigue
12 month
|
3.05 units on a scale
Standard Deviation 1.06
|
2.77 units on a scale
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: 4 month (post treatment), 8 month follow/up, 12 month follow/upPopulation: Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.
The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Mastery looks at the patient's perceived control over the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health
Outcome measures
| Measure |
ACCESS
n=101 Participants
Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
|
Enhanced Usual Care
n=74 Participants
Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
|
|---|---|---|
|
Chronic Respiratory Questionnaire_Mastery
4 month
|
4.25 units on a scale
Standard Deviation 1.14
|
3.51 units on a scale
Standard Deviation 1.19
|
|
Chronic Respiratory Questionnaire_Mastery
8 month
|
4.20 units on a scale
Standard Deviation 1.20
|
3.45 units on a scale
Standard Deviation 1.22
|
|
Chronic Respiratory Questionnaire_Mastery
12 month
|
3.96 units on a scale
Standard Deviation 1.11
|
3.62 units on a scale
Standard Deviation 1.28
|
PRIMARY outcome
Timeframe: 4 month (post treatment), 8 month follow/up, 12 month follow/upPopulation: Only patients experiencing chronic lung problems (Chronic Obstructive Pulmonary Disease, emphysema, bronchitis, asthma) completed this assessment.
The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Dyspnea looks at how much shortness of breath a patient experiences. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.
Outcome measures
| Measure |
ACCESS
n=101 Participants
Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
|
Enhanced Usual Care
n=74 Participants
Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
|
|---|---|---|
|
Chronic Respiratory Questionnaire_Dyspnea
4 month
|
3.37 units on a scale
Standard Deviation 1.15
|
2.94 units on a scale
Standard Deviation .98
|
|
Chronic Respiratory Questionnaire_Dyspnea
8 month
|
3.27 units on a scale
Standard Deviation 1.02
|
3.03 units on a scale
Standard Deviation .89
|
|
Chronic Respiratory Questionnaire_Dyspnea
12 month
|
3.07 units on a scale
Standard Deviation .99
|
3.11 units on a scale
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: 4 month (post treatment), 8 month follow/up, and 12 month follow/upPopulation: Only patients randomized for heart failure was required to complete the assessment. There were fewer patients randomized for congestive heart failure (CHF) as compared to COPD.
The KCCQ measures the health status of patients with congestive heart failure. The overall score is a mean score scaled from 0 - 100; where 0 represents most severe/limited functioning.
Outcome measures
| Measure |
ACCESS
n=46 Participants
Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
|
Enhanced Usual Care
n=40 Participants
Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
4 month
|
40.25 units on a scale
Standard Deviation 15.12
|
41.81 units on a scale
Standard Deviation 19.21
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
8 month
|
41.34 units on a scale
Standard Deviation 19.89
|
36.23 units on a scale
Standard Deviation 18.21
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
12 month
|
42.89 units on a scale
Standard Deviation 18.30
|
41.68 units on a scale
Standard Deviation 20.81
|
Adverse Events
ACCESS
Serious events: 8 serious events
Other events: 57 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 9 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACCESS
n=180 participants at risk
ACCESS: Participants received 6 treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completing core modules the participant was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
|
Enhanced Usual Care
n=122 participants at risk
Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
|
|---|---|---|
|
Investigations
Death
|
2.2%
4/180 • Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study.
Although there were adverse events during the course of the study, none were determined to be related to the study.
|
4.1%
5/122 • Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study.
Although there were adverse events during the course of the study, none were determined to be related to the study.
|
|
Cardiac disorders
Hospitalizations
|
2.2%
4/180 • Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study.
Although there were adverse events during the course of the study, none were determined to be related to the study.
|
3.3%
4/122 • Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study.
Although there were adverse events during the course of the study, none were determined to be related to the study.
|
Other adverse events
| Measure |
ACCESS
n=180 participants at risk
ACCESS: Participants received 6 treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completing core modules the participant was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
|
Enhanced Usual Care
n=122 participants at risk
Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
18.3%
33/180 • Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study.
Although there were adverse events during the course of the study, none were determined to be related to the study.
|
19.7%
24/122 • Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study.
Although there were adverse events during the course of the study, none were determined to be related to the study.
|
|
Psychiatric disorders
Anxiety
|
13.3%
24/180 • Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study.
Although there were adverse events during the course of the study, none were determined to be related to the study.
|
23.0%
28/122 • Data on Adverse events was collected for a period of 1 year. This is the length of time participants were in the study.
Although there were adverse events during the course of the study, none were determined to be related to the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place