Evidence map›Paper›PMID 38956612›Full record

ArticleTrials2024

Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA).

Jaideep C Menon, Denny John, Aswathy Sreedevi, Chandrasekhar Janakiram, Akshaya R, Sumithra S, Aravind M S, Mathews Numpeli, Bipin Gopal, Renjini B A and 3 more

Erratum issuedAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Jaideep C MenonAdult Cardiology, AIMS, Amrita Vishwa Vidyapeetham, Kochi, India.
Denny JohnRamaiah University of Applied Sciences, Bengaluru, India.
Aswathy SreedeviCommunity Medicine, AIMS, Amrita Vishwa Vidyapeetham, Kochi, India. draswathygopan@gmail.com.ORCID http://orcid.org/0000-0002-6037-9265
Chandrasekhar JanakiramPublic Health Dentistry, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Kochi, India.
Akshaya RCommunity Medicine, AIMS, Amrita Vishwa Vidyapeetham, Kochi, India.
Sumithra SStJohn's Research Institute, Bangalore, India.
Aravind M SAIMS, Kochi, India.
Mathews NumpeliMO, DHS, Govt of Kerala, Ernakulam, India.
Bipin GopalNCD, DHS, Govt of Kerala, Kerala, Thiruvananthapuram, India.
Renjini B AMO, DHS, Govt of Kerala, Ernakulam, India.
Sajeev P KCHC, Kalady, Kalady, India.
Ravivarman LakshmanasamyIndia Country Office, New Delhi, India.
Abhishek KunwarNPO NCD, WHO India, New Delhi, India.

Funding

World Health Organization 001World Health Organization 2023/1376413-0
6 · The paper itself

Abstract

backgroundCardiovascular disease (CVD) is the leading cause of mortality worldwide, and at present, India has the highest burden of acute coronary syndrome and ST-elevation myocardial infarction (MI). A key reason for poor outcomes is non-adherence to medication.

methodsThe intervention is a 2 × 2 factorial design trial applying two interventions individually and in combination with 1:1 allocation ratio: (i) ASHA-led medication adherence initiative comprising of home visits and (ii) m-health intervention using reminders and self-reporting of medication use. This design will lead to four potential experimental conditions: (i) ASHA-led intervention, (ii) m-health intervention, (iii) ASHA and m-health intervention combination, (iv) standard of care. The cluster randomized trial has been chosen as it randomizes communities instead of individuals, avoiding contamination between participants. Subcenters are a natural subset of the health system, and they will be considered as the cluster/unit. The factorial cluster randomized controlled trial (cRCT) will also incorporate a nested health economic evaluation to assess the cost-effectiveness and return on investment (ROI) of the interventions on medication adherence among patients with CVDs. The sample size has been calculated to be 393 individuals per arm with 4-5 subcenters in each arm. A process evaluation to understand the effect of the intervention in terms of acceptability, adoption (uptake), appropriateness, costs, feasibility, fidelity, penetration (integration of a practice within a specific setting), and sustainability will be done. DISCUSSION: The effect of different types of intervention alone and in combination will be assessed using a cluster randomized design involving 18 subcenter areas. The trial will explore local knowledge and perceptions and empower people by shifting the onus onto themselves for their medication adherence. The proposal is aligned to the WHO-NCD aims of improving the availability of the affordable basic technologies and essential medicines, training the health workforce and strengthening the capacity of at the primary care level, to address the control of NCDs. The proposal also helps expand the use of digital technologies to increase health service access and efficacy for NCD treatment and may help reduce cost of treatment.

trial registrationThe trial has been registered with the Clinical Trial Registry of India (CTRI), reference number CTRI/2023/10/059095.

Indexed as

Cardiovascular DiseasesCommunity Health WorkersMedication AdherenceRandomized Controlled Trials as TopicCardiovascular AgentsCost-Benefit AnalysisHouse CallsHumansImplementation ScienceIndiaMulticenter Studies as TopicReminder SystemsTelemedicineTreatment OutcomeCardiovascular AgentsArrhythmiaCoronary artery diseaseFactorial study designHeart failureImplementation ResearchMedication adherenceMorisky Medication Adherence ScaleValvular disease

Identifiers

PMID38956612
PMCPMC11221042

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.