Short- and long-term effects of real-time medication monitoring with short message service (SMS) reminders for missed doses on the refill adherence of people with Type 2 diabetes: evidence from a randomized controlled trial

2014 ◽  
Vol 31 (7) ◽  
pp. 821-828 ◽  
Author(s):  
M. Vervloet ◽  
L. van Dijk ◽  
D. H. de Bakker ◽  
P. C. Souverein ◽  
J. Santen-Reestman ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Short Message ◽  
Long Term Effects ◽  
Randomized Controlled ◽  
Medication Monitoring ◽  
Message Service ◽  
Sms Reminders ◽  
Short And Long Term

scholarly journals Immediate and Long-Term Effects of an 8-Week Digital Mental Health Intervention on Adults With Poorly Managed Type 2 Diabetes: Protocol for a Randomized Controlled Trial

10.2196/18578 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e18578
Author(s):  
Eliane Boucher ◽  
Judith T Moskowitz ◽  
Gina M Kackloudis ◽  
Julia L Stafford ◽  
Ian Kwok ◽  
...  
Keyword(s):  
Mental Health ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Long Term Effects ◽  
Randomized Controlled ◽  
Short And Long Term ◽  
Therapeutic Platform

Background Diabetes is a leading cause of years of life lost and accounts for approximately one-fourth of health care dollars spent in the United States. Many of these costs are related to poor medication adherence and lack of self-care behaviors and are thus preventable. Depression, which is more prevalent among people with diabetes than in the general population, predicts poorer management of one’s diabetes, whereas positive affect predicts engaging in more positive health behaviors. Consequently, interventions that improve depression and positive affect may also improve diabetes-related outcomes among people with diabetes. Although preliminary research on the impact of such interventions among people with diabetes is promising, these studies focused primarily on in-person interventions, have had small samples, and lack long-term follow-up. Objective This study aims to examine the short- and long-term effects of a digital therapeutic platform focused on mental health among adults with poorly managed type 2 diabetes and elevated levels of depression. Methods This is a randomized controlled trial in which adults with a type 2 diabetes diagnosis, elevated hemoglobin A1c (HbA1c) levels (≧7), and moderate to severe depressive symptoms will be randomly assigned to a positive emotion regulation skills intervention group or a sham digital intervention with only psychoeducational content. The study will take place over 14 months, including the 8-week intervention (or control) delivered via a digital therapeutic platform (Happify Health) and follow-up assessments at 3, 6, and 12 months postintervention. Throughout the intervention and for 1 week at each postintervention follow-up, participants will complete daily assessments of diabetes-related distress, diabetes regimen adherence, and mood. Our primary outcome, HbA1c, will be self-reported every 3 months throughout the study. Secondary and exploratory outcomes will be assessed at baseline; at 8 weeks; and at 3, 6, and 12 months postintervention. Results Recruitment is expected to begin in June 2020. Participants will begin the study as they are recruited and will finish in waves. The final wave of data collection from the 8-week intervention is expected for winter 2020, with the completion of the 12-month follow-up in winter 2021. Conclusions Although previous research suggests that in-person psychological interventions have promising effects on both psychological and physical outcomes among adults with diabetes, digital interventions can be advantageous because they are easily scalable and reduce many barriers that prevent people from seeking treatment. This trial will provide important information about the effects of a digital mental health intervention among adults with type 2 diabetes, assessing both short- and long-term effects of this intervention on HbA1c, depressive symptoms, and other diabetes-specific outcomes. If successful, this may introduce a scalable intervention that would help reduce some of the preventable costs associated with diabetes. Trial Registration ClinicalTrials.gov NCT04068805; https://clinicaltrials.gov/ct2/show/NCT04068805. International Registered Report Identifier (IRRID) PRR1-10.2196/18578

scholarly journals Immediate and Long-Term Effects of an 8-Week Digital Mental Health Intervention on Adults With Poorly Managed Type 2 Diabetes: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Eliane Boucher ◽  
Judith T Moskowitz ◽  
Gina M Kackloudis ◽  
Julia L Stafford ◽  
Ian Kwok ◽  
...  
Keyword(s):  
Mental Health ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Long Term Effects ◽  
Randomized Controlled ◽  
Short And Long Term ◽  
Therapeutic Platform

BACKGROUND Diabetes is a leading cause of years of life lost and accounts for approximately one-fourth of health care dollars spent in the United States. Many of these costs are related to poor medication adherence and lack of self-care behaviors and are thus preventable. Depression, which is more prevalent among people with diabetes than in the general population, predicts poorer management of one’s diabetes, whereas positive affect predicts engaging in more positive health behaviors. Consequently, interventions that improve depression and positive affect may also improve diabetes-related outcomes among people with diabetes. Although preliminary research on the impact of such interventions among people with diabetes is promising, these studies focused primarily on in-person interventions, have had small samples, and lack long-term follow-up. OBJECTIVE This study aims to examine the short- and long-term effects of a digital therapeutic platform focused on mental health among adults with poorly managed type 2 diabetes and elevated levels of depression. METHODS This is a randomized controlled trial in which adults with a type 2 diabetes diagnosis, elevated hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) levels (≧7), and moderate to severe depressive symptoms will be randomly assigned to a positive emotion regulation skills intervention group or a sham digital intervention with only psychoeducational content. The study will take place over 14 months, including the 8-week intervention (or control) delivered via a digital therapeutic platform (Happify Health) and follow-up assessments at 3, 6, and 12 months postintervention. Throughout the intervention and for 1 week at each postintervention follow-up, participants will complete daily assessments of diabetes-related distress, diabetes regimen adherence, and mood. Our primary outcome, HbA<sub>1c</sub>, will be self-reported every 3 months throughout the study. Secondary and exploratory outcomes will be assessed at baseline; at 8 weeks; and at 3, 6, and 12 months postintervention. RESULTS Recruitment is expected to begin in June 2020. Participants will begin the study as they are recruited and will finish in waves. The final wave of data collection from the 8-week intervention is expected for winter 2020, with the completion of the 12-month follow-up in winter 2021. CONCLUSIONS Although previous research suggests that in-person psychological interventions have promising effects on both psychological and physical outcomes among adults with diabetes, digital interventions can be advantageous because they are easily scalable and reduce many barriers that prevent people from seeking treatment. This trial will provide important information about the effects of a digital mental health intervention among adults with type 2 diabetes, assessing both short- and long-term effects of this intervention on HbA1c, depressive symptoms, and other diabetes-specific outcomes. If successful, this may introduce a scalable intervention that would help reduce some of the preventable costs associated with diabetes. CLINICALTRIAL ClinicalTrials.gov NCT04068805; https://clinicaltrials.gov/ct2/show/NCT04068805. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/18578

The Short- and Long-term Effects of Simple Behavioral Interventions for Nocturnal Enuresis in Young Children: A Randomized Controlled Trial

2009 ◽  
Vol 154 (5) ◽  
pp. 662-666.e1 ◽  
Author(s):  
Paula van Dommelen ◽  
Mascha Kamphuis ◽  
Frank J.M. van Leerdam ◽  
Jeroen A. de Wilde ◽  
Ab Rijpstra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young Children ◽  
Behavioral Interventions ◽  
Nocturnal Enuresis ◽  
Controlled Trial ◽  
Long Term Effects ◽  
Randomized Controlled ◽  
Short And Long Term
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