Health Behavior Nudge Strategies for Chronic Disease Patients: the Study of Hypertension and Type 2 Diabetes

NCT06588127 | Active Not Recruiting

• 1 other identifier: 722740872020
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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\' 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.

Conditions

Economics, Behavioral; Hypertension; Type 2 Diabetes Mellitus (T2DM); Self-management Behavior; Health Behavior

Outcome Measures

Primary Outcomes (1)

• Self-management behavior

  The self-management behaviors of T2DM patients were evaluated using the Diabetes Self-Care Scale (DSCS), encompasses six dimensions: dietary control, regular exercise, medication adherence, blood glucose monitoring, foot care, and management of high/low blood sugar, consisting of a total of 26 items rated on a 5-point Likert scale, with higher total scores reflecting greater levels of the behaviors. The self-management behaviors of hypertensive patients were assessed using the Chinese Self-Management Behavior Assessment Scale for Hypertensive Patients, which includes six dimensions and 33 items: exercise management, health monitoring, work and rest management, emotional management, medication management, and dietary management, all rated on a 5-point Likert scale, with a minimum score of 33 and a maximum of 165. The higher scores mean a better outcome. These scales are answered by patients according to their actual situation.

  Baseline, 3rd month, 6th month

Secondary Outcomes (6)

• Activity of Daily Living

  Baseline, 3rd month, 6th month

• Life quality

  Baseline, 3rd month, 6th month

• Blood pressure(BP)

  Baseline, 3rd month, 6th month

• Blood sugar

  Baseline, 3rd month, 6th month

• Body Mass Index(BMI)

  Baseline, 3rd month, 6th month

Study Arms (2)

Nudge Group

EXPERIMENTAL

The research formed an intervention team comprising 1 project leader, 2 project members, 1 community general practitioner, and 3 community nurses. The project leader oversees the project's progress and quality, while the project members implement specific intervention measures. The community general practitioner addresses the health issues faced by patients in their daily lives, and the nurses communicate with both patients and project team members. The intervention is executed on-site and online, with online efforts primarily utilizing WeChat, a widely used social tool in China. The research will span 6 months, with data collection occurring at baseline, 3, and 6 months.

Behavioral: nudge

Control Group

NO INTERVENTION

According to the Basic Public Health Service Specification of China and the Prevention and Control Management Guidelines for Hypertension and Diabetes in Primary Health care, routine community care for HP and T2DM patients should be conducted, including monitoring blood pressure and blood sugar, follow-up on the health status of patients, and distribution of community health promotion materials.

Interventions

nudge BEHAVIORAL

Nudge interventions are developed based on the scoping review and qualitative research by the research team, which involves commitment (behavioral contracts), norms (case and experience sharing), significance and framing effects (posters, health behavior identification posts), reminders, and incentives (arteriosclerosis detection). The content encompasses diet, physical activity, medication management, self-monitoring, and control of smoking and alcohol. From the viewpoint of bounded rationality in behavioral economics, and drawing on prior research that has pinpointed decision-making biases in patients' self-management behaviors, nudging strategies have been developed to assist individuals in overcoming these biases or to utilize the patterns of these biases to steer them toward making choices that are in line with their health.

Nudge Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lin Han: lead

Study Sites (1)

School of nursing, Lanzhou University

Lanzhou, Gansu, China

Location

Related Publications (7)

• 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.

  PMID: 28755061 BACKGROUND

• 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.

  PMID: 38776869 BACKGROUND

• 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.

  PMID: 34933021 BACKGROUND

• 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.

  PMID: 36871213 BACKGROUND

• 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.

  PMID: 24359583 BACKGROUND

• 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.

  PMID: 31515735 BACKGROUND

• 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.

  PMID: 25145577 BACKGROUND

MeSH Terms

Conditions

Behavior; Hypertension; Diabetes Mellitus, Type 2; Health Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Fanghong Yan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: prof

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)