iMedA: Improving MEDication Adherence Through Person-Centered Care and Adaptive Interventions

NCT04413500 | Unknown DMC

• 1 other identifier: 2017-04617
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to design, implement, and evaluate an adaptive personalized digital intervention, to be delivered through a mobile application, to increase medication adherence and self-care management for persons with hypertension. This is a collaborative project between Halmstad University and Region Halland in Halland county, Sweden. The project is divided into three steps: 1)Focus groups 2)pilot study 3)Longitudinal study. The design of the study is influenced by the Intervention Mapping technique, which is used for the design and development of health promotion programs. The investigators first conducted a systematic review in order to detect the determinants, behaviors to change, and implemented digital strategies in the previous studies. The result was drawn in the Matrix of Change Objectives to facilitate the mapping. Then through focus groups, the investigators are going to ascertain the needs of the Swedish context. Through what has been learned with these findings, digital interventions will be designed and developed to be delivered via mobile application. A pilot study is considered then to evaluate the feasibility and usability testing of digital intervention. Finally, a longitudinal study is designed to evaluate the effectiveness of the digital intervention in the longer term. The design is proposed to be an interrupted time series (ITS) approach which is considered to be the strongest quasi-experimental design that can be used to evaluate the effectiveness of an intervention.

Conditions

Hypertension

Keywords

hypertension; digital intervention; adaptive intervention

Outcome Measures

Primary Outcomes (1)

• change from baseline medication adherence score at 6 months

  medication adherence score (MA) measured through the Maastricht Utrecht Adherence in Hypertension (MUAH-16) questionnaire. The higher score is correlated to better medication adherence. MUAH-16 has 4 subscales: 2 of them measures positive and the other 2 measures negative aspects of medication adherence. Therefore, we consider a positive score for the 2 positive subscales and negative scores to the negative ones. The result will be the final score showing the medication adherence score of the participant. The answers are supposed to be on a 7-point Likert scale (1: completely disagree and 7:completely agree). Therefore, the max score will be 48 and the min score will be -48. Based on the previous study, there has been shown a correlation between having a higher score and higher medication adherence.

  6 months

Secondary Outcomes (3)

• change from baseline Blood pressure at 6 months

  6 months

• change from baseline health literacy score at 6 months

  6 months

• change from baseline Quality of Life at 6 months

  6 months

Other Outcomes (3)

• medication intake rate

  through study completion, an average of 6 months

• physical activity

  through study completion, an average of 6 months

• change from baseline medication pickups from pharmacies at 6 months

  6 months

Study Arms (1)

adaptive intervention

EXPERIMENTAL

The patients will receive various adaptive digital interventions through mobile app.

Behavioral: Reminder; Behavioral: Educational message; Behavioral: Motivational messages; Behavioral: showing trends

Interventions

Reminder BEHAVIORAL

A reminder to take the anti-hypertension medication with adjustable frequency.

adaptive intervention

Educational message BEHAVIORAL

An educational message to increase the knowledge about various facts around hypertension. The short messages are supposed to be sent based on the patient's needs.

adaptive intervention

Motivational messages BEHAVIORAL

The motivational short messages to increase the motivational levels.

adaptive intervention

showing trends BEHAVIORAL

Short messages contain different trends of medication intake rate, BP, physical activity rate, and so on.

adaptive intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 40-70 years old
• have hypertension diagnosis (i.e. ICD 10 codes from I10 to I16 in the person's medical history) for 1 year or more and have prescribed medications;
• not receiving medication with unit-dose packaged (Apodos);
• no previous stroke or myocardial infarction;
• no psychological disorder or cognitive impairment;
• no pregnancy-induced hypertension;
• no insulin treatment;
• no kidney disease defined as glomerular filtration rate (GFR) \<60 ml/min

You may not qualify if:

• have no own smartphone
• not understanding the Swedish language both spoken and written

Sponsors & Collaborators

• Halmstad University: lead
• Region Halland: collaborator

Related Publications (5)

• Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.

  PMID: 27663578 BACKGROUND

• Cabral AC, Castel-Branco M, Caramona M, Fernandez-Llimos F, Figueiredo IV. Developing an adherence in hypertension questionnaire short version: MUAH-16. J Clin Hypertens (Greenwich). 2018 Jan;20(1):118-124. doi: 10.1111/jch.13137. Epub 2017 Nov 24.

  PMID: 29171719 BACKGROUND

• Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002 Aug;27(4):299-309. doi: 10.1046/j.1365-2710.2002.00430.x.

  PMID: 12174032 BACKGROUND

• Etminani K, Tao Engstrom A, Goransson C, Sant'Anna A, Nowaczyk S. How Behavior Change Strategies are Used to Design Digital Interventions to Improve Medication Adherence and Blood Pressure Among Patients With Hypertension: Systematic Review. J Med Internet Res. 2020 Apr 9;22(4):e17201. doi: 10.2196/17201.

  PMID: 32271148 RESULT

• Etminani K, Goransson C, Galozy A, Norell Pejner M, Nowaczyk S. Improving Medication Adherence Through Adaptive Digital Interventions (iMedA) in Patients With Hypertension: Protocol for an Interrupted Time Series Study. JMIR Res Protoc. 2021 May 12;10(5):e24494. doi: 10.2196/24494.

  PMID: 33978593 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kobra Etminani

  Halmstad University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kobra Etminani

CONTACT

+46729773851; kobra.etminani@hh.se

Slawomir Nowaczyk

CONTACT

slawomir.nowaczyk@hh.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at CAISR, department of ISDD, School of ITE, HH

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: September 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share