Clinical trial NCT06807567: Acceptability and Feasibility of Interventions for Integrated Care of Chronic Kidney Disease With Other Long-term Health Conditions in Malawi: a Qualitative Study
Official title: Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi to Inform Interventions for Earlier Detection ad Prevention (Impso Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Kidney Disease(CKD)
Multimorbidity
Long-term Health Conditions
Keywords: integrated care
chronic kidney disease
long-term conditions
qualitative research
Malawi
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Wellcome Trust (Liverpool Clinical PhD Programme)
First posted: 2025-02-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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

Brief 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.


Eligibility criteria: 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
   * HIV 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:

* • 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

Primary outcomes:
measure: Codes and themes
timeFrame: 6 months from end of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Malawi Liverpool Wellcome Clinical Research Programme
Study officials:
References: