Trial Outcomes & Findings for e-Mobile Tablet for People With Chronic Conditions (NCT NCT02833311)
NCT ID: NCT02833311
Last Updated: 2023-05-12
Results Overview
Physical Activity and Disability Survey-Revised was administered to assess physical activity behavior. Scores can range from -2.7493 to 3.3671. Higher scores on the Physical Activity and Disability Survey-Revised indicates increased physical activity levels.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Outcomes were administered immediately before the intervention and again 6-weeks later
Results posted on
2023-05-12
Participant Flow
Participant milestones
| Measure |
Computer Tablet Group
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
Computer Tablet Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.
|
Paper and Pencil Group
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Paper and Pencil Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.
|
Standard Treatment Control Group
Participants are prescribed an exercise program and given information on healthy eating.
Standard Treatment Control Group: Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
e-Mobile Tablet for People With Chronic Conditions
Baseline characteristics by cohort
| Measure |
Computer Tablet Group
n=15 Participants
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
Computer Tablet Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.
|
Paper and Pencil Group
n=16 Participants
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Paper and Pencil Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.
|
Standard Treatment Control Group
n=15 Participants
Participants are prescribed an exercise program and given information on healthy eating.
Standard Treatment Control Group: Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
36 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Age, Continuous
|
58.93 years
STANDARD_DEVIATION 5.52 • n=93 Participants
|
59.38 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
55 years
STANDARD_DEVIATION 11.58 • n=27 Participants
|
57.8 years
STANDARD_DEVIATION 9.48 • n=483 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
16 participants
n=4 Participants
|
15 participants
n=27 Participants
|
46 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Outcomes were administered immediately before the intervention and again 6-weeks laterPhysical Activity and Disability Survey-Revised was administered to assess physical activity behavior. Scores can range from -2.7493 to 3.3671. Higher scores on the Physical Activity and Disability Survey-Revised indicates increased physical activity levels.
Outcome measures
| Measure |
Computer Tablet Group
n=13 Participants
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
Computer Tablet Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.
|
Paper and Pencil Group
n=15 Participants
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Paper and Pencil Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.
|
Contact Control Group
n=15 Participants
Participants are prescribed an exercise program and given information on healthy eating.
Standard Treatment Control Group: Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.
|
|---|---|---|---|
|
Changes From Baseline in Physical Activity
Pretest
|
0.36 units on a scale
Standard Deviation 0.77
|
0.31 units on a scale
Standard Deviation 1.01
|
0.43 units on a scale
Standard Deviation 0.68
|
|
Changes From Baseline in Physical Activity
Posttest
|
0.76 units on a scale
Standard Deviation 0.92
|
0.55 units on a scale
Standard Deviation 1.15
|
0.36 units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Outcomes were administered immediately before the intervention and again 6-weeks laterPatient Reported Outcome Measurement information System (PROMIS) Physical Function (PF) was used to measure self-report physical function. Measures are scored on a T-score metric. High scores indicate more of the concept being measured. A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population.
Outcome measures
| Measure |
Computer Tablet Group
n=13 Participants
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
Computer Tablet Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.
|
Paper and Pencil Group
n=15 Participants
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Paper and Pencil Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.
|
Contact Control Group
n=15 Participants
Participants are prescribed an exercise program and given information on healthy eating.
Standard Treatment Control Group: Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.
|
|---|---|---|---|
|
Changes From Baseline in Self-Report Physical Function
Pretest
|
39.87 units on a scale
Standard Deviation 5.87
|
38.89 units on a scale
Standard Deviation 3.14
|
42.44 units on a scale
Standard Deviation 5.45
|
|
Changes From Baseline in Self-Report Physical Function
Posttest
|
38.44 units on a scale
Standard Deviation 7.54
|
37.91 units on a scale
Standard Deviation 4.52
|
41.51 units on a scale
Standard Deviation 3.96
|
SECONDARY outcome
Timeframe: Outcomes were administered immediately before the intervention and again 6-weeks laterOutcome measures
| Measure |
Computer Tablet Group
n=13 Participants
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
Computer Tablet Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.
|
Paper and Pencil Group
n=15 Participants
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Paper and Pencil Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.
|
Contact Control Group
n=15 Participants
Participants are prescribed an exercise program and given information on healthy eating.
Standard Treatment Control Group: Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.
|
|---|---|---|---|
|
Changes From Baseline in 6-minute Walking Test
Pretest
|
303.69 meters
Standard Deviation 87.23
|
316.32 meters
Standard Deviation 117.58
|
362.32 meters
Standard Deviation 91.01
|
|
Changes From Baseline in 6-minute Walking Test
Posttest
|
327.46 meters
Standard Deviation 68.32
|
320.61 meters
Standard Deviation 122.02
|
385.23 meters
Standard Deviation 82.26
|
SECONDARY outcome
Timeframe: Outcomes were administered immediately before the intervention and again 6-weeks laterExercise Confidence Survey was used to measure self-efficacy. The survey asks about confidence in sticking to an exercise program and making time for exercise. This is a 12 item questionnaire and scores ranges from 1 to 60. A higher score indicates increased confidence to engage in exercise.
Outcome measures
| Measure |
Computer Tablet Group
n=13 Participants
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
Computer Tablet Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.
|
Paper and Pencil Group
n=15 Participants
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Paper and Pencil Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.
|
Contact Control Group
n=15 Participants
Participants are prescribed an exercise program and given information on healthy eating.
Standard Treatment Control Group: Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.
|
|---|---|---|---|
|
Changes From Baseline in Self-Efficacy
Pretest
|
3.26 units on a scale
Standard Deviation 0.96
|
3.29 units on a scale
Standard Deviation 0.91
|
3.33 units on a scale
Standard Deviation 0.45
|
|
Changes From Baseline in Self-Efficacy
Posttest
|
3.25 units on a scale
Standard Deviation 0.82
|
3.42 units on a scale
Standard Deviation 0.76
|
2.97 units on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Outcomes were administered immediately before the intervention and again 6-weeks laterPopulation: 3 participants (2 in the computer tablet group and 1 in the paper and pencil group) were missing weight data for posttest timepoint. These participants were removed from analysis.
Outcome measures
| Measure |
Computer Tablet Group
n=13 Participants
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
Computer Tablet Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.
|
Paper and Pencil Group
n=15 Participants
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Paper and Pencil Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.
|
Contact Control Group
n=15 Participants
Participants are prescribed an exercise program and given information on healthy eating.
Standard Treatment Control Group: Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.
|
|---|---|---|---|
|
Changes From Baseline in Weight
Posttest
|
91.32 kg
Standard Deviation 27.97
|
87.58 kg
Standard Deviation 20.12
|
81.56 kg
Standard Deviation 23.05
|
|
Changes From Baseline in Weight
Pretest
|
91.78 kg
Standard Deviation 28.50
|
88.80 kg
Standard Deviation 22.12
|
81.71 kg
Standard Deviation 22.64
|
Adverse Events
Computer Tablet Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Paper and Pencil Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Treatment Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Computer Tablet Group
n=15 participants at risk
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
Computer Tablet Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.
|
Paper and Pencil Group
n=16 participants at risk
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Paper and Pencil Group: Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.
|
Standard Treatment Control Group
n=15 participants at risk
Participants are prescribed an exercise program and given information on healthy eating.
Standard Treatment Control Group: Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.
|
|---|---|---|---|
|
General disorders
Falls
|
20.0%
3/15
|
18.8%
3/16
|
6.7%
1/15
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place