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NCT Number: NCT06807567

Acceptability and Feasibility of Interventions for Integrated Care of Chronic Kidney Disease With Other Long-term Health Conditions in Malawi: a Qualitative Study

The burden of chronic kidney disease (CKD) is rising globally, but disproportionately impacting on low- and middle-income countries (LMIC) including Malawi, which have the fewest resources to manage it. Furthermore, CKD is the leading cause of catastrophic health expenditure worldwide, largely due to the extremely high costs of kidney replacement therapy (KRT) for people with kidney failure. Access to KRT remains limited in many settings, including Malawi, where there is only one nephrologist for a population of over 21 million. It is therefore essential to diagnose and treat CKD in its early stages, to facilitate earlier and more cost-effective treatment to prevent its progression to advanced disease which is associated with increased risks of kidney failure and of cardiovascular morbidity and mortality. CKD is usually asymptomatic in its early stages, so early diagnosis and treatments requires access to key diagnostic tests, in addition to strategies for channelling resources to those at the highest risk.

The causes of CKD are diverse, particularly in LMIC settings where the increasing prevalence of non-communicable diseases intersects with ongoing high burdens of infectious diseases, malnutrition, and many other social and environmental determinants of kidney health. The World Health Organization recommends integrated approaches to improve equity of quality care for people living with long-term conditions, and CKD would be amenable to integrated approaches, however CKD has been neglected from global NCD agendas and there is little data to guide the most effective methods for integrating its care with other long-term conditions (such as hypertension, diabetes and HIV infection), particularly in low-income settings such as Malawi.

The aim of this study is to explore current experiences of care for CKD and related long-term conditions, and to qualitatively evaluate the acceptability and feasibility of different potential approaches to integrating their care, amongst different stakeholders groups in Malawi.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Malawi Liverpool Wellcome Clinical Research Programme

Blantyre, Malawi

Location contact

Brian Ngwira

CONTACT

[email protected]

+265 993888275

Charlotte M Snead

CONTACT

[email protected]

Charlotte Snead

SUB_INVESTIGATOR

Chimota Phiri

SUB_INVESTIGATOR

Felix Limbani

SUB_INVESTIGATOR

Henry Mwandumba

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligibility criteria for each of the participant groups described above are as follows:

Patients:

  • Adults aged ≥ 18 years
  • Diagnosed with CKD, or at risk of CKD, AND at least one other long-term health condition out of:
  • Hypertension
  • Diabetes mellitus
  • HIV infection
  • Heart failure
  • Stroke (See Table 1 for diagnostic inclusion criteria for each of the above conditions)
  • Receiving outpatient care at one of the selected study sites, for at least 6 months

Caregivers:

  • Adults aged ≥ 18 years
  • Identified by a patient meeting the above inclusion criteria to be their primary caregiver

Healthcare workers:

  • Adults aged ≥ 18 years
  • Currently employed as a healthcare worker at either QECH, Chiradzulu District Hospital, Ndunde Health Centre or Namadzi Health Centre.
  • Working in an outpatient clinic environments where care is delivered for patients with any of the above conditions, which may include (but is not limited to) the following:
  • CKD clinic (QECH)
  • Hypertension clinic (QECH)
  • Diabetes clinic (QECH)
  • HIV clinic (all study locations, including the Lighthouse clinic at QECH)
  • Cardiology /chest clinic (QECH)
  • General non-communicable disease (Chiradzulu District Hospital and its referring primary health centres)

Policy makers

  • Adults aged ≥ 18 years
  • Identified through stakeholder mapping and/or snowball sampling to have a leading role relevant to planning, managing and implementing services and/or policies for NCDs and/or other LTCs.

Exclusion criteria

  • • Under 18 years of age
  • Acute physical or mental illness, which requires urgent treatment and might impact on ability to participate in and complete interview
  • Current hospital inpatient
  • Unable to participate in interview due to severe communication difficulties (e.g. aphasia), confusion or behavioural disturbance
  • Declines consent

Treatment and study plan

Receipt of healthcare for long-term conditions

Other

The patient participants are people who are already receiving healthcare for CKD and/or hypertension, diabetes, HIV, heart failure and/or stroke at one of the named study sites, for at least 6 months prior to recruitment into this qualitative study. The caregiver participants are caregivers for patients meeting these criteria.

Provision of healthcare

Other

The healthcare worker participants are all providing care to patients with long-tem conditions, at one of the names study sites

Policy making

Other

The policy makers recruited to this study will be individuals involved in policy making for long-term conditions in Malawi

Primary outcomes

  1. Codes and themes

    Time frame: 6 months from end of data collection

    The outcomes of this study will be the codes and themes identified through thematic analysis of the interview and focus group discussion transcripts.

Sponsors and collaborators

Lead sponsor

Liverpool School of Tropical Medicine

Other

Collaborators

  • Wellcome Trust (Liverpool Clinical PhD Programme)

Registry information

Official study title

Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi to Inform Interventions for Earlier Detection ad Prevention (Impso Study)

Acronym: Impso

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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