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Article ; Online: The effect of a multi-component behavior change technique intervention on physical activity among individuals on primary prevention statin therapy: A dose-finding trial protocol.

Butler, Mark J / Romain, Anne-Marie N / Augustin, Rumisha / Robles, Patrick / Friel, Ciaran P / Vicari, Frank / Chandereng, Thevaa / Alfano, Catherine M / Cheung, Ying-Kuen / Davidson, Karina W

Contemporary clinical trials

2023 Volume 130, Page(s) 107205

Abstract: Background: Statin therapy is a mainstay of cardiovascular disease (CVD) prevention, but research shows that statin therapy alone is insufficient for preventing incident CVD and mortality. Combining statin medication with increased physical activity (PA) ...

Abstract	Background: Statin therapy is a mainstay of cardiovascular disease (CVD) prevention, but research shows that statin therapy alone is insufficient for preventing incident CVD and mortality. Combining statin medication with increased physical activity (PA) can lower mortality risk more than either statin or PA alone. However, PA levels often remain the same and may even decline following statin prescription. Additional information is needed to identify how to increase PA among statin users and determine the minimal length of an intervention (i.e., intervention dose) necessary to increase PA. Objective: The study aims to identify the required dose of a behavior change technique (BCT) intervention to increase PA among individuals on primary prevention statin therapy who have an elevated risk for cardiovascular disease (CVD). Methods: The study will utilize the modified time-to-event continual reassessment method (TiTE-CRM) in 42 participants. We expect insights relating to dose-efficacy models and BCTs (Behavior Change Techniques) to improve PA in adults at risk for CVD. This trial will also examine potential mechanisms of action (MoAs) for interventions to increase PA, identify any effect a PA intervention may have on medication adherence, and determine whether participants respond uniformly to their respective behavioral interventions. Ethics and dissemination: This trial was approved by the Northwell Health Institutional Review Board (IRB) and all participants will complete informed consent. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines. Registration details: This trial is registered on www. Clinicaltrials: gov (Number NCT05273723).
MeSH term(s)	Adult ; Humans ; Behavior Therapy ; Cardiovascular Diseases/prevention & control ; Exercise ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Primary Prevention/methods
Chemical Substances	Hydroxymethylglutaryl-CoA Reductase Inhibitors
Language	English
Publishing date	2023-04-25
Publishing country	United States
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2182176-8
ISSN	1559-2030 ; 1551-7144
ISSN (online)	1559-2030
ISSN	1551-7144
DOI	10.1016/j.cct.2023.107205
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol.

Butler, Mark J / Romain, Anne-Marie N / Augustin, Rumisha / Robles, Patrick / Friel, Ciaran P / Chandereng, Thevaa / Suls, Jerry M / Vrany, Elizabeth A / Vicari, Frank / Cheung, Ying Kuen / Davidson, Karina W

Trials

2023 Volume 24, Issue 1, Page(s) 523

Abstract: Background: In the USA, the primary cause of death and morbidity continues to be cardiovascular disease (CVD). Numerous trials have shown that statin medication reduces the likelihood of CVD events; it is a cornerstone of CVD prevention. However, ... ...

Abstract	Background: In the USA, the primary cause of death and morbidity continues to be cardiovascular disease (CVD). Numerous trials have shown that statin medication reduces the likelihood of CVD events; it is a cornerstone of CVD prevention. However, studies have also indicated that up to 60% of the estimated 26.8 million Americans prescribed primary prevention statin treatment are nonadherent during the first year. Multi-component behavioral change technique (BCT) therapies have shown moderate promise in improving medication adherence as well as other positive health behaviors (such as physical activity). However, no research has looked at the duration of multi-component BCT intervention needed to result in a clinically significant improvement in statin adherence behaviors. This study aims to determine the necessary dose of a multi-component BCT intervention (defined as duration in weeks) to promote adherence to statin medication among those on primary prevention statin treatment by utilizing the modified time-to-event continuous reassessment method (TiTE-CRM). Methods and design: The study will utilize the modified TiTE-CRM in 42 participants, recruited in 14 cohorts of 3 participants each. The goal of this analysis is to identify the minimum effective dose (MED) of a multi-behavior change technique (BCT) intervention required to increase adherence to statins by 20% between baseline and follow-up periods. Using the TiTE-CRM method, the dose of the behavior intervention in weeks will be assigned to each cohort based on the performance of the prior cohort. At the end of the study, the intervention dose that has been found to be associated with a 20% increase in statin adherence among 80% of participants assigned to that dose will be identified as the MED. Discussion: If successful, the current trial will provide additional guidance to researchers and clinicians seeking to increase statin medication adherence using a BCT intervention by identifying the dose (i.e., the duration) of an intervention required to meaningfully increase adherence. Trial registration: ClinicalTrials.gov NCT05273736. Registered on March 10, 2022. https://www. Clinicaltrials: gov/ct2/show/NCT05273736.
MeSH term(s)	Humans ; Behavior Therapy ; Cardiovascular Diseases/diagnosis ; Cardiovascular Diseases/prevention & control ; Cardiovascular Diseases/drug therapy ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use ; Medication Adherence ; Primary Prevention/methods
Chemical Substances	Hydroxymethylglutaryl-CoA Reductase Inhibitors
Language	English
Publishing date	2023-08-12
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-023-07549-w
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: EEG biofeedback in the treatment of attention deficit hyperactivity disorder.

Friel, Patrick N

Alternative medicine review : a journal of clinical therapeutic

2007 Volume 12, Issue 2, Page(s) 146–151

Abstract: Electroencephalogram (EEG) biofeedback, also known as neurofeedback, is a promising alternative treatment for patients with attention deficit/hyperactivity disorder (AD/HD). EEG biofeedback therapy rewards scalp EEG frequencies that are associated with ... ...

Abstract	Electroencephalogram (EEG) biofeedback, also known as neurofeedback, is a promising alternative treatment for patients with attention deficit/hyperactivity disorder (AD/HD). EEG biofeedback therapy rewards scalp EEG frequencies that are associated with relaxed attention, and suppresses frequencies associated with under- or over-arousal. In large-scale clinical trials, the efficacy of EEG biofeedback for AD/HD is comparable to that of stimulant medications. Many different EEG biofeedback protocols for AD/HD are available. Single-channel protocols developed by Lubar and interhemispheric protocols developed by the Othmers are widely practiced and supported by large-scale clinical studies.
MeSH term(s)	Attention Deficit Disorder with Hyperactivity/therapy ; Biofeedback, Psychology/methods ; Clinical Trials as Topic ; Electroencephalography/adverse effects ; Electroencephalography/methods ; Humans
Language	English
Publishing date	2007-06
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1465535-4
ISSN	1089-5159
ISSN	1089-5159
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Article: Feasibility Test of Personalized (N-of-1) Trials for Increasing Middle-Aged and Older Adults' Physical Activity.

Friel, Ciarán P / Goodwin, Ashley M / Robles, Patrick L / Butler, Mark J / Pahlevan-Ibrekic, Challace / Duer-Hefele, Joan / Vicari, Frank / Gordon, Samantha / Chandereng, Thevaa / Cheung, Ying Kuen Ken / Davidson, Karina W

Research square

2023

Abstract: ... physical activity (walking) in middle-aged and older adults.: Design: This study used a Personalized (N-of-1 ...

Abstract	Purpose: To test the feasibility of a remotely-delivered intervention to increase low-intensity physical activity (walking) in middle-aged and older adults. Design: This study used a Personalized (N-of-1) trial design. Setting: This study took place at a major healthcare system from November 2021 to February 2022. Subjects: Sixty adults (45-75 years, 92% female, 80% white) were recruited. Intervention: A 10-week study comprising a 2-week baseline, followed by four 2-week periods where 4 Behavior Change Techniques (BCTs) - self-monitoring, goal setting, action planning and feedback - were delivered one at a time in random order. Measures: Activity was measured by a Fitbit, and intervention components delivered by email/text. Average daily steps were compared between baseline and intervention. Participants completed satisfaction items derived from the System Usability Scale and reported attitudes and opinions about personalized trials. Results: Participants rated personalized trial components as feasible and acceptable. Changes in steps between baseline and intervention were not significant, but a large heterogeneity of treatment effects existed, suggesting some participants significantly increased walking while others significantly decreased. Conclusions: Our intervention was well-accepted but use of BCTs delivered individually did not result in a significant increase in steps. Feasibility and heterogeneity of treatment effects support adopting a personalized trial approach to optimize intervention results.
Language	English
Publishing date	2023-12-28
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-3788631/v1
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Protocol of a feasibility study of a virtual personalized (N-of-1) trial for increasing low-intensity physical activity in older adults via habit formation.

Suls, Jerry / Friel, Ciarán P / Butler, Mark / Duer-Hefele, Joan / Robles, Patrick L / Vicari, Frank / Chandereng, Thevaa / Cheung, Ying Kuen Ken / Davidson, Karina W

Contemporary clinical trials communications

2023 Volume 33, Page(s) 101135

Abstract: Background: Personalized interventions that can be delivered remotely are needed to increase physical activity (PA) in older adults to reduce risk of CV disease and mortality. Prior research indicates that Behavioral Change Techniques (BCTs) (e.g., goal ...

Abstract	Background: Personalized interventions that can be delivered remotely are needed to increase physical activity (PA) in older adults to reduce risk of CV disease and mortality. Prior research indicates that Behavioral Change Techniques (BCTs) (e.g., goal setting, self-monitoring, behavioral repetition) can instill a habit for increasing daily walking. However, past interventions relied on between-subject randomized clinical trials, which can only only be informative about response of the hypothetical average person. Personalized trial designs can identify the benefits of an intervention for a specific individual although extended periods are required for collecting frequent measurements within-subject. Advances in remote, virtual technologies (e.g., text messaging, activity trackers), integrated with automatic platforms, can meet these requirements because they capacitate delivery of BCT interventions, and collection of data during daily life without personal contact. This Stage I-b trial is designed test whether a virtual, personalized intervention is feasible and acceptable to older adults, can elicit participant adherence and exhibit preliminary evidence for efficacy. Methods: A series of up to 60 single-arm, personalized trials, involving no personal contact, will recruit adults, 45-75 years of age, to wear an activity tracker during a 2-week baseline and a 10-week intervention. Five BCT prompts to execute a walking plan will be delivered on a daily basis during the intervention phase. Participants will rate satisfaction with personalized trial components and whether automaticity of the walking plan can be achieved. Step-counts, adherence to the walking plan and self-monitoring of step-count will also be recorded.
Language	English
Publishing date	2023-06-05
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2023.101135
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Testing Behavior Change Techniques to Increase Physical Activity in Middle-Aged and Older Adults: Protocol for a Randomized Personalized Trial Series.

Friel, Ciaran P / Robles, Patrick L / Butler, Mark / Pahlevan-Ibrekic, Challace / Duer-Hefele, Joan / Vicari, Frank / Chandereng, Thevaa / Cheung, Ken / Suls, Jerry / Davidson, Karina W

JMIR research protocols

2023 Volume 12, Page(s) e43418

Abstract: ... influential for a given individual. In contrast, a personalized, or N-of-1, trial design can assess a person's ...

Abstract	Background: Being physically active is critical to successful aging, but most middle-aged and older adults do not move enough. Research has shown that even small increases in activity can have a significant impact on risk reduction and improve quality of life. Some behavior change techniques (BCTs) can increase activity, but prior studies on their effectiveness have primarily tested them in between-subjects trials and in aggregate. These design approaches, while robust, fail to identify those BCTs most influential for a given individual. In contrast, a personalized, or N-of-1, trial design can assess a person's response to each specific intervention. Objective: This study is designed to test the feasibility, acceptability, and preliminary effectiveness of a remotely delivered personalized behavioral intervention to increase low-intensity physical activity (ie, walking) in adults aged 45 to 75 years. Methods: The intervention will be administered over 10 weeks, starting with a 2-week baseline period followed by 4 BCTs (goal-setting, self-monitoring, feedback, and action planning) delivered one at a time, each for 2 weeks. In total, 60 participants will be randomized post baseline to 1 of 24 intervention sequences. Physical activity will be continuously measured by a wearable activity tracker, and intervention components and outcome measures will be delivered and collected by email, SMS text messages, and surveys. The effect of the overall intervention on step counts relative to baseline will be examined using generalized linear mixed models with an autoregressive model that accounts for possible autocorrelation and linear trends for daily steps across time. Participant satisfaction with the study components and attitudes and opinions toward personalized trials will be measured at the intervention's conclusion. Results: Pooled change in daily step count will be reported between baseline and individual BCTs and baseline versus overall intervention. Self-efficacy scores will be compared between baseline and individual BCTs and between baseline and the overall intervention. Mean and SD will be reported for survey measures (participant satisfaction with study components and attitudes and opinions toward personalized trials). Conclusions: Assessing the feasibility and acceptability of delivering a personalized, remote physical activity intervention for middle-aged and older adults will inform what steps will be needed to scale up to a fully powered and within-subjects experimental design remotely. Examining the effect of each BCT in isolation will allow for their unique impact to be assessed and support design of future behavioral interventions. In using a personalized trial design, the heterogeneity of individual responses for each BCT can be quantified and inform later National Institutes of Health stages of intervention development trials. Trial registration: clinicaltrials.gov NCT04967313; https://clinicaltrials.gov/ct2/show/NCT04967313. International registered report identifier (irrid): RR1-10.2196/43418.
Language	English
Publishing date	2023-06-14
Publishing country	Canada
Document type	Journal Article
ZDB-ID	2719222-2
ISSN	1929-0748
ISSN	1929-0748
DOI	10.2196/43418
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Prasterone and bone mineral density in women with systemic lupus erythematosus.

Alexander, Thomas / Friel, Patrick N / Wright, Jonathan V

The Journal of rheumatology

2005 Volume 32, Issue 12, Page(s) 2497; author reply 2497–8

MeSH term(s)	Adjuvants, Immunologic/therapeutic use ; Bone Density/drug effects ; Dehydroepiandrosterone/therapeutic use ; Female ; Humans ; Lupus Erythematosus, Systemic/drug therapy ; Lupus Erythematosus, Systemic/metabolism
Chemical Substances	Adjuvants, Immunologic ; Dehydroepiandrosterone (459AG36T1B)
Language	English
Publishing date	2005-12
Publishing country	Canada
Document type	Comment ; Letter
ZDB-ID	194928-7
ISSN	1499-2752 ; 0315-162X
ISSN (online)	1499-2752
ISSN	0315-162X
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 1168: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 135: Show issues

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Article: Suppression of adrenal function by low-dose prednisone: assessment with 24-hour urinary steroid hormone profiles--a review of five cases.

Friel, Patrick N / Alexander, Thomas / Wright, Jonathan V

Alternative medicine review : a journal of clinical therapeutic

2006 Volume 11, Issue 1, Page(s) 40–46

Abstract: The impact of the synthetic glucocorticoid prednisone on adrenal steroid hormone production was examined using 24-hour urinary steroid hormone profiling. Five women, who were chronically taking low-dose prednisone, were tested, and the relevant ... ...

Abstract	The impact of the synthetic glucocorticoid prednisone on adrenal steroid hormone production was examined using 24-hour urinary steroid hormone profiling. Five women, who were chronically taking low-dose prednisone, were tested, and the relevant literature was reviewed. As expected, adrenal glucocorticoid production, measured by urinary terminal cortisol and cortisone metabolites, was markedly suppressed compared to reference range values (p=0.03). Urinary cortisol and cortisone, reflecting circulating glucocorticoids, were decreased to a lesser extent than their terminal metabolites. Urinary dehydroepiandrosterone (DHEA) excretion was dramatically suppressed (p=0.03), while the downstream androgen metabolites androsterone and etiocholanolone were suppressed to a lesser extent. Aldosterone and tetrahydrocorticosterone production demonstrated modest suppression after prednisone administration, but allo-tetrahydrocorticosterone, which is highly sensitive to adrenocorticotropic hormone (ACTH) secretion, was suppressed to a greater extent. Prednisone administration results in a decrease in ACTH secretion by the anterior pituitary, suppressing synthesis of glucocorticoids, DHEA, and DHEA metabolites. Decreased glucocorticoid synthesis is adaptive, because prednisone is active at the glucocorticoid receptor, but suppression of DHEA synthesis is not mitigated by prednisone. DHEA is an important sex hormone precursor, neurosteroid, and endocrine and immune modulator; therefore, DHEA depletion may have significant adverse consequences in terms of sex hormone production, bone health, endocrine and immune system function, and neuropsychiatric status. Studies of DHEA replacement in patients taking prednisone for lupus demonstrate amelioration of some of these adverse effects.
MeSH term(s)	Adrenal Glands/drug effects ; Adrenal Glands/metabolism ; Adrenal Insufficiency/chemically induced ; Adrenal Insufficiency/urine ; Adult ; Aldosterone/urine ; Androsterone/urine ; Anti-Inflammatory Agents/administration & dosage ; Anti-Inflammatory Agents/adverse effects ; Cortisone/urine ; Dehydroepiandrosterone/urine ; Etiocholanolone/urine ; Female ; Humans ; Hydrocortisone/urine ; Middle Aged ; Prednisone/administration & dosage ; Prednisone/adverse effects
Chemical Substances	Anti-Inflammatory Agents ; Dehydroepiandrosterone (459AG36T1B) ; Aldosterone (4964P6T9RB) ; Etiocholanolone (97CGB1M48I) ; Androsterone (C24W7J5D5R) ; Cortisone (V27W9254FZ) ; Prednisone (VB0R961HZT) ; Hydrocortisone (WI4X0X7BPJ)
Language	English
Publishing date	2006-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	1465535-4
ISSN	1089-5159
ISSN	1089-5159
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 4997: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (2.OG)
ab Jg. 2022: Lesesaal (EG)

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Article ; Online: Protocol of a feasibility study of a virtual personalized (N-of-1) trial for increasing low-intensity physical activity in older adults via habit formation

Jerry Suls / Ciarán P. Friel / Mark Butler / Joan Duer-Hefele / Patrick L. Robles / Frank Vicari / Thevaa Chandereng / Ying Kuen (Ken) Cheung / Karina W. Davidson

Contemporary Clinical Trials Communications, Vol 33, Iss , Pp 101135- (2023)

2023

Abstract	Background: Personalized interventions that can be delivered remotely are needed to increase physical activity (PA) in older adults to reduce risk of CV disease and mortality. Prior research indicates that Behavioral Change Techniques (BCTs) (e.g., goal setting, self-monitoring, behavioral repetition) can instill a habit for increasing daily walking. However, past interventions relied on between-subject randomized clinical trials, which can only only be informative about response of the hypothetical average person. Personalized trial designs can identify the benefits of an intervention for a specific individual although extended periods are required for collecting frequent measurements within-subject. Advances in remote, virtual technologies (e.g., text messaging, activity trackers), integrated with automatic platforms, can meet these requirements because they capacitate delivery of BCT interventions, and collection of data during daily life without personal contact. This Stage I-b trial is designed test whether a virtual, personalized intervention is feasible and acceptable to older adults, can elicit participant adherence and exhibit preliminary evidence for efficacy. Methods: A series of up to 60 single-arm, personalized trials, involving no personal contact, will recruit adults, 45–75 years of age, to wear an activity tracker during a 2-week baseline and a 10-week intervention. Five BCT prompts to execute a walking plan will be delivered on a daily basis during the intervention phase. Participants will rate satisfaction with personalized trial components and whether automaticity of the walking plan can be achieved. Step-counts, adherence to the walking plan and self-monitoring of step-count will also be recorded.
Keywords	Personalized trial ; N-of-1 ; Habit formation ; Physical activity ; older adults ; Medicine (General) ; R5-920
Subject code	796
Language	English
Publishing date	2023-06-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Hormone replacement with estradiol: conventional oral doses result in excessive exposure to estrone.

Friel, Patrick N / Hinchcliffe, Christa / Wright, Jonathan V

Alternative medicine review : a journal of clinical therapeutic

2005 Volume 10, Issue 1, Page(s) 36–41

Abstract: Background: There is a lack of consensus about the safety of estrogen replacement therapy, especially with regard to its impact on a woman's risk for breast cancer. Elevated urinary or serum estrone and estradiol concentrations in postmenopausal women ... ...

Abstract	Background: There is a lack of consensus about the safety of estrogen replacement therapy, especially with regard to its impact on a woman's risk for breast cancer. Elevated urinary or serum estrone and estradiol concentrations in postmenopausal women are associated with a moderately elevated risk of breast cancer. Methods: Twenty-four-hour urinary steroid hormone profiles, including the measurement of estrone, estradiol, and estriol, were conducted for 35 postmenopausal women receiving oral estradiol at doses from 0.025-2.0 mg/day. Results: Urinary excretion of estradiol exceeded premenopausal reference range values in women taking estradiol at doses greater than 0.5 mg/day. Urinary estrone excretion exceeded premenopausal reference range values in women taking estradiol doses of 0.25 mg/day or higher. Literature data indicate serum estrone concentrations also markedly exceed premenopausal reference ranges when estradiol is administered orally at a dose of 1 mg/day. Conclusions: The previously recommended oral dose of estradiol (1-2 mg/day) results in urinary excretion of estrone at values 5-10 times the upper limit of the reference range for premenopausal women. Retrospective studies associating oral estradiol with increased risk of breast cancer may reflect overdose conditions. Based on current knowledge, a prudent dose ceiling for oral estradiol replacement therapy of 0.25 mg/day is proposed.
MeSH term(s)	Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Estradiol/administration & dosage ; Estradiol/urine ; Estriol/urine ; Estrone/blood ; Estrone/urine ; Female ; Hormone Replacement Therapy/adverse effects ; Humans ; Middle Aged ; Reference Values ; Regression Analysis
Chemical Substances	Estrone (2DI9HA706A) ; Estradiol (4TI98Z838E) ; Estriol (FB33469R8E)
Language	English
Publishing date	2005-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	1465535-4
ISSN	1089-5159
ISSN	1089-5159
Database	MEDical Literature Analysis and Retrieval System OnLINE

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