Clinical trial NCT06588127: Health Behavior Nudge Strategies for Chronic Disease Patients: the Study of Hypertension and Type 2 Diabetes
Official title: Health Behavior Nudge Strategies for Chronic Disease Patients: the Study of Hypertension and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Economics, Behavioral
Hypertension
Type 2 Diabetes Mellitus (T2DM)
Self-management Behavior
Health Behavior
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Select two communities of comparable size and level, with one community recruiting participants as a control group and the other community recruiting participants as an intervention group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is conducted from the perspective of behavioral economics, where individuals often display bounded rationality in decision-making, opting for habitual choices rather than those most advantageous to themselves. Nudge strategies can utilize individuals\&#39; cognitive and motivational shortcomings to influence behavior. Therefore, the study first examines the decision-making biases present in patients with hypertension (HP) and type 2 diabetes mellitus (T2DM) regarding the maintenance of healthy behaviors based on individuals' bounded rationality; subsequently, it develops an intervention program to encourage healthy behaviors in HP and T2DM patients alongside nudge strategies; finally, it assesses the intervention effects of the program on blood pressure, blood glucose, and health behaviors in HP and T2DM patients.

Detailed description: The study was conducted in Lanzhou City, Gansu Province, China. The research selected two communities of similar scale and level, recruiting 133 patients with HP and T2DM. A six-month quasi-experimental study was performed, where the intervention group implemented nudging strategies while the control group received standard community nursing. By measuring the patients\&amp;#39; blood pressure and blood glucose levels, and utilizing the Diabetes Self-Care Scale, Hypertension Self-Management Behavior rang Scale，Patient Activation Measure，Short-Form Health Survey, Activity of Daily Living Scale to assess the behavioral changes in both groups, validated the intervention effect of the nudging strategy on the health behaviors of patients with HP and T2DM.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Previously diagnosed with hypertension, type 2 diabetes, or hypertension combined with type 2 diabetes
* Able to use mobile phones or other electronic devices
* Informed consent

Exclusion Criteria:

* Patients who are pregnant or breastfeeding;
* Patients with severe diabetes, hypertension complications, or other serious illnesses;
* Patients with hearing or vision impairments;
* Patients with cognitive impairments or mental illnesses;
* Patients with acute complications.

Primary outcomes:
measure: Self-management behavior
timeFrame: Baseline, 3rd month, 6th month
Secondary outcomes:
measure: Activity of Daily Living
timeFrame: Baseline, 3rd month, 6th month
measure: Life quality
timeFrame: Baseline, 3rd month, 6th month
measure: Blood pressure(BP)
timeFrame: Baseline, 3rd month, 6th month
measure: Blood sugar
timeFrame: Baseline, 3rd month, 6th month
measure: Body Mass Index(BMI)
timeFrame: Baseline, 3rd month, 6th month
measure: Patient Activation Measure
timeFrame: Baseline, 3rd month, 6th month
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: School of nursing, Lanzhou University
state: Gansu
Study officials:
name: Fanghong Yan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kullgren JT, Hafez D, Fedewa A, Heisler M. A Scoping Review of Behavioral Economic Interventions for Prevention and Treatment of Type 2 Diabetes Mellitus. Curr Diab Rep. 2017 Sep;17(9):73. doi: 10.1007/s11892-017-0894-z.
citation: Peng G, Yan F, Sun R, Zhang Y, Zhao R, Zhang G, Qiao P, Ma Y, Han L. Self-management behavior strategy based on behavioral economics in patients with hypertension: a scoping review. Transl Behav Med. 2024 Jun 27;14(7):405-416. doi: 10.1093/tbm/ibae018.
citation: Forberger S, Wichmann F, Comito CN. Nudges used to promote physical activity and to reduce sedentary behaviour in the workplace: Results of a scoping review. Prev Med. 2022 Feb;155:106922. doi: 10.1016/j.ypmed.2021.106922. Epub 2021 Dec 18.
citation: Modin D, Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Claggett BL, Dueger EL, Samson SI, Loiacono MM, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Jean-Marie Martel C, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Effect of Electronic Nudges on Influenza Vaccination Rate in Older Adults With Cardiovascular Disease: Prespecified Analysis of the NUDGE-FLU Trial. Circulation. 2023 May 2;147(18):1345-1354. doi: 10.1161/CIRCULATIONAHA.123.064270. Epub 2023 Mar 5.
citation: Hollands GJ, Shemilt I, Marteau TM, Jebb SA, Kelly MP, Nakamura R, Suhrcke M, Ogilvie D. Altering micro-environments to change population health behaviour: towards an evidence base for choice architecture interventions. BMC Public Health. 2013 Dec 21;13:1218. doi: 10.1186/1471-2458-13-1218.
citation: Shapiro MF, Shu SB, Goldstein NJ, Victor RG, Fox CR, Tseng CH, Vangala S, Mogler BK, Reed SB, Villa E, Escarce JJ. Impact of a Patient-Centered Behavioral Economics Intervention on Hypertension Control in a Highly Disadvantaged Population: a Randomized Trial. J Gen Intern Med. 2020 Jan;35(1):70-78. doi: 10.1007/s11606-019-05269-z. Epub 2019 Sep 12.
citation: Blumenthal-Barby JS, Krieger H. Cognitive biases and heuristics in medical decision making: a critical review using a systematic search strategy. Med Decis Making. 2015 May;35(4):539-57. doi: 10.1177/0272989X14547740. Epub 2014 Aug 21.