ClinicalTrials.gg
Not yet recruitingNCT06807567ImpsoUpdated Feb 4, 2025

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

An observational study in Chronic Kidney Disease(CKD), Multimorbidity and Long-term Health Conditions, sponsored by Liverpool School of Tropical Medicine. Not yet recruiting at 1 site in Malawi. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Liverpool School of Tropical Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Kidney Disease(CKD)
  • Multimorbidity
  • Long-term Health Conditions

Keywords

  • integrated care
  • chronic kidney disease
  • long-term conditions
  • qualitative research
  • Malawi
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 60 is below the median of 213 across 834 observational studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Liverpool School of Tropical Medicine is the lead sponsor of 57 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  • We will recruit adults aged 18 years and older from the following stakeholder groups:
  • Patients
  • Caregivers
  • Healthcare workers (HCWs)
  • Policy makers

Patients will be adults with, or at risk of, CKD and at least one other long-term health condition, who receive outpatient care at Queen Elizabeth Central Hospital (QECH) in Blantyre, Chiradzulu District Hospital or primary health centres within Chiradzulu district.

  • Caregivers of patients from meeting eligibility criteria will also be invited to participate, if they are identified by the patient to be their primary caregiver.
  • Healthcare workers (HCWs) will be recruited from amongst staff working at any of the named study locations, whose role involves caring for patients with CKD and/or other long-term health conditions.
  • Policy makers will be individuals with leading roles in planning, managing and implementing services and policies for non-communicable diseases and/or other long-term conditions in Malawi

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Patients:

  1. Adults aged ≥ 18 years
  2. Diagnosed with CKD, or at risk of CKD, AND at least one other long-term health condition out of:

    • Hypertension
    • Diabetes mellitus
    • infection
    • Heart failure
    • Stroke (See Table 1 for diagnostic inclusion criteria for each of the above conditions)
  3. Receiving outpatient care at one of the selected study sites, for at least 6 months

Caregivers:

  1. Adults aged ≥ 18 years
  2. 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients and caregivers

    Patients aged 18 years and over with CKD, or at risk of CKD, who have at least one other long-term condition, and who are receiving care at either Queen Elizabeth Central Hospital in Blantyre, Chiradzulu District Hospital, Namadzi or Ndunde primary health care centres. Caregivers will be the caregivers of patients meeting these conditions.

    Other: Receipt of healthcare for long-term conditions

  • Healthcare workers

    Healthcare workers, aged 18 years and over, providing care for patients with CKD and other long-term health conditions at Queen Elizabeth Central Hospital in Blantyre, Chiradzulu District Hospital, Namadzi or Ndunde primary health care centres.

    Other: Provision of healthcare

  • Policy makers

    Policy makers with roles in policy making related to CKD and other long-term health conditions in Malawi.

    Other: Policy making

Interventions

  • OtherReceipt of healthcare for long-term conditions

    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.

  • OtherProvision of healthcare

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

  • OtherPolicy making

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

06

What researchers measure

Primary outcomes

  1. Codes and themes

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

    Time frame: 6 months from end of data collection

07

Study locations

1 site
  • Malawi Liverpool Wellcome Clinical Research Programme
    Blantyre, Malawi
    • Brian Ngwira · Contactbngwira@mlw.mw · +265 993888275
    • Charlotte M Snead · Contactcharlotte.snead@lstmed.ac.uk
    • Henry Mwandumba · Principal investigator
    • Felix Limbani · Sub investigator
    • Chimota Phiri · Sub investigator
    • Charlotte Snead · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes — Access may be granted to pseudonymised interview transcripts to approved researchers for the purposes of secondary analyses, only following completion of the analysis and subject to approval by the Malawi Liverpool Wellcome Programme (MLW) research strategy group.

Supporting information: Clinical study report, Analytic code

Time frame: After completion of the main analysis, and up to a maximum of 5 years after completion fo the study

Access criteria: Subject to application to the MLW research strategy group and their approval

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06807567
Lead sponsor
Liverpool School of Tropical Medicine
Collaborators
Wellcome Trust (Liverpool Clinical PhD Programme)
Responsible party
Sponsor
First posted
Feb 4, 2025
Start date
Feb 17, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Mar 5, 2026 (estimated)
Last update
Feb 4, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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