Changes in Patient-Reported Outcome Measures With a Technology-Supported Behavioral Lifestyle Intervention Among Patients With Type 2 Diabetes: Pilot Randomized Controlled Clinical Trial

Background In the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ≥65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients’ perception of health and quantify the impact of disease processes or intervention effects. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of health. Objective This study examined the feasibility of collecting Patient-Reported Outcome Measurement Information System (PROMIS) measures, and preliminarily evaluated changes in PROMIS scores and compared the scores with standard scores of the general US population. The parent study is a pilot randomized controlled clinical trial testing three different modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight or obese patients with T2D. Methods Patients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to the following three groups: mHealth, paper diary, and control (standard of care) groups. Paper diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions, as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes the following seven domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of the following two domains: global mental health and global physical health. Results A total of 26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m2. All patients completed the PROMIS-57 and PROMIS-GH questionnaires, and we compared the mean scores of the three groups to investigate potential differences. No relevant differences were noted across the groups. However, positive trends were noted in both intervention (mHealth and paper diary) groups in the middle (month 3) and end (month 6) of the study. Conclusions Our pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D-related symptoms among overweight or obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention. Trial Registration ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648

Download Full-text

Changes in Patient-Reported Outcome Measures With a Technology-Supported Behavioral Lifestyle Intervention Among Patients With Type 2 Diabetes: Pilot Randomized Controlled Clinical Trial (Preprint)

10.2196/preprints.19268 ◽

2020 ◽

Author(s):

Rozmin Jiwani ◽

Jing Wang ◽

Andrea Berndt ◽

Padmavathy Ramaswamy ◽

Nitha Mathew Joseph ◽

...

Keyword(s):

Lifestyle Intervention ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Paper Diary ◽

Patient Reported ◽

And Control

BACKGROUND In the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ≥65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients’ perception of health and quantify the impact of disease processes or intervention effects. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of health. OBJECTIVE This study examined the feasibility of collecting Patient-Reported Outcome Measurement Information System (PROMIS) measures, and preliminarily evaluated changes in PROMIS scores and compared the scores with standard scores of the general US population. The parent study is a pilot randomized controlled clinical trial testing three different modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight or obese patients with T2D. METHODS Patients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to the following three groups: mHealth, paper diary, and control (standard of care) groups. Paper diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions, as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes the following seven domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of the following two domains: global mental health and global physical health. RESULTS A total of 26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m<sup>2</sup>. All patients completed the PROMIS-57 and PROMIS-GH questionnaires, and we compared the mean scores of the three groups to investigate potential differences. No relevant differences were noted across the groups. However, positive trends were noted in both intervention (mHealth and paper diary) groups in the middle (month 3) and end (month 6) of the study. CONCLUSIONS Our pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D-related symptoms among overweight or obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention. CLINICALTRIAL ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648

Download Full-text

The Effects of Berberis integerrima Fruit Extract on Glycemic Control Parameters in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/5583691 ◽

2021 ◽

Vol 2021 ◽

pp. 1-7

Author(s):

Rasool Soltani ◽

Syed Mustafa Ghanadian ◽

Bijan Iraj ◽

Alireza Homayouni ◽

Tanin Shahmiveh Esfahani ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Clinical Trial ◽

Standard Treatment ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Fruit Extract ◽

Randomized Controlled ◽

And Control

Background. Berberis integerrima Bunge fruits have been utilized in traditional medicine to control diabetes mellitus (DM). However, no clinical survey has been done in this regard. This study was conducted to clinically evaluate the effects of fruit extract of this plant in improving glycemic control indices in patients with type 2 DM (T2DM). Methods. In a randomized controlled clinical trial, patients with T2DM who met the inclusion criteria were randomly divided into two groups of drug (Berberis) and control to receive the extract solution 5 ml twice daily (equivalent to 1000 mg of dry extract) with standard treatment (metformin) or only standard treatment, respectively, for 8 weeks. Before and after the intervention, fasting blood sugar (FBS), serum glycosylated hemoglobin (HbA1c), serum insulin, the homeostasis assessment model for insulin resistance (HOMA-IR), body mass index (BMI), and systolic and diastolic blood pressure were determined and compared between the two groups. Results. During the study, 30 and 35 patients in the drug and control groups, respectively, completed the study. Although no significant changes occurred in any parameter within each group, postintervention FBS (117.5 [107–128.8] versus 134 [120–142], P = 0.001 ) and HbA1c (7 [6.4–7.7] versus 7.5 [6.8–7.9], P = 0.045 ) were significantly lower in the drug group than in the control one. In terms of other parameters, there were no significant differences between the groups. Conclusion. Consumption of B. integerrima Bunge fruit extract at a dosage of 1000 mg daily decreases FBS and HbA1c but does not affect HOMA-IR in patients with type 2 diabetes mellitus.

Download Full-text

Effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes: a systematic review protocol

BMJ Open ◽

10.1136/bmjopen-2020-044888 ◽

2021 ◽

Vol 11 (3) ◽

pp. e044888

Author(s):

Rita McMorrow ◽

Barbara Hunter ◽

Christel Hendrieckx ◽

Dominika Kwasnicka ◽

Leanne Cussen ◽

...

Keyword(s):

Systematic Review ◽

Type 2 Diabetes ◽

Outcome Measures ◽

Study Design ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Diabetes Distress ◽

Controlled Trials ◽

Patient Reported

IntroductionType 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes.Methods and analysisMEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case–control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate.Ethics and disseminationEthics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations.PROSPERO registration numberCRD42020200246.

Download Full-text