Trial Outcomes & Findings for Multicomponent Telecare Model for Supporting Prediabetes Patients (NCT NCT01671293)
NCT ID: NCT01671293
Last Updated: 2015-06-30
Results Overview
Patient's weight wil be measured in kilograms using scales.
COMPLETED
NA
70 participants
baseline and post intervention (6 -9 months after the first phone counseling session)
2015-06-30
Participant Flow
Participant milestones
| Measure |
Multicomponent Remote Care Model
Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
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Usual Care
Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
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|---|---|---|
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Overall Study
STARTED
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36
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34
|
|
Overall Study
COMPLETED
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicomponent Telecare Model for Supporting Prediabetes Patients
Baseline characteristics by cohort
| Measure |
Multicomponent Remote Care Model
n=36 Participants
Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
|
Usual Care
n=34 Participants
Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
|
Total
n=70 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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50.78 years
STANDARD_DEVIATION 8.46 • n=5 Participants
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54.88 years
STANDARD_DEVIATION 8.59 • n=7 Participants
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52.77 years
STANDARD_DEVIATION 8.71 • n=5 Participants
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Sex: Female, Male
Female
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26 Participants
n=5 Participants
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20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
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24 Participants
n=5 Participants
|
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Region of Enrollment
Chile
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36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and post intervention (6 -9 months after the first phone counseling session)Patient's weight wil be measured in kilograms using scales.
Outcome measures
| Measure |
Multicomponent Remote Care Model
n=33 Participants
Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
|
Usual Care
n=32 Participants
Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
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|---|---|---|
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Change From Baseline in Weight Parameter
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-.58 kilograms
Standard Deviation 2.98
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-.18 kilograms
Standard Deviation 2.47
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SECONDARY outcome
Timeframe: baseline and post intervention (6 -9 months after the first phone counseling session)The level of physical activity reported by participants is measured using the Rapid Assessment Physical Activity Scale (RAPA; Tolpolski et al., 2006), in its version adapted for Chile. This instrument is made up by 9 dichotomous questions, which point to a physical activity level corresponding to the following categories: sedentary, under-active, under-active regular-light activities, under-active regular, and active, depending on the frequency and intensity of the physical activity done. The instrument adaptation process of the instrument is conducted as part of the present study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and post intervention (6 -9 months after the first phone counseling session)Fasting Glucose will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols: Method:Colorimetric - Hexokinase / Glucose 6-phosphate-DH. UV. Equipment: Siemens Dimension RXL. Normal Range: 70-100 mg/dL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and post intervention (6 -9 months after the first phone counseling session)It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols: Method:Colorimetric - GPO/PAP blank glycerol. Equipment: Siemens Dimension RXL. Normal Range: ≤ 150 mg/dL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and post intervention (6 -9 months after the first phone counseling session)It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols: Method: Colorimetric - CHOD/PAP.Equipment: Siemens Dimension RXL. Normal Range: ≤ 200 mg/dL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and post intervention (6 -9 months after the first phone counseling session)The dietary practices reported by the participants will be measured with an instrument designed with this purpose in mind as part of the present study. The instrument is constituted by 17 items aimed at measuring the frequency of healthy and unhealthy eating. It was constructed on the basis of items present in the Diabetes Self Care Activities Measure (Toobert, Hampson, \& Glasgow, 2000) and of others created by the Stanford Patient Education Research Center. Some of these items were used to measure dietary practices in Chilean populations diagnosed with Diabetes Mellitus (Lange et al., 2010)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and post intervention (6 -9 months after the first phone counseling session)A self-report questionnaire was developed to measure patients' knowledge about prediabetes, the risk factors for its appearance, and its treatment (or management). Is is made up by 18 items in which the person must say whether the statement presented is true or false. In addition, the instrument measures the subjective perception of the risk of developing diabetes (one item).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and post intervention (6 -9 months after the first phone counseling session)Participants' waist circumference will be measured in centimeters using a measuring tape. The circumference will be measured at the highest part of the iliac crest (The Canadian Physical Activity, Fitness and Lifestyle approach, 2010)
Outcome measures
Outcome data not reported
Adverse Events
Multicomponent Remote Care Model
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multicomponent Remote Care Model
n=36 participants at risk
Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
|
Usual Care
n=34 participants at risk
Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
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|---|---|---|
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Musculoskeletal and connective tissue disorders
falls
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5.6%
2/36 • During the intervention time frame
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0.00%
0/34 • During the intervention time frame
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place