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Completed

NCT Number: NCT06248190

ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE

The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are:

1. To test and estimate the effect of the intervention in people with MLTCs attending

PHCs on:

i. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care 2. To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance. 3. To understand implementation processes and outcomes within the wider context of primary healthcare, provide explanations for the observed effects of the clinical findings and identify recommendations for wider implementation of the ENHANCE intervention.

The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.

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Key information

Conditions

HIV Infections Asthma Behavior Behavioral Symptoms Blood-Borne Infections Brain Diseases Bronchial Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Communicable Diseases Depression Diabetes Mellitus Disease Attributes Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders Heart Diseases Hypersensitivity Hypersensitivity, Immediate Hypertension Immune System Diseases Immunologic Deficiency Syndromes Infarction Infections Ischemia Lentivirus Infections Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Multiple Chronic Conditions Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Hypersensitivity Respiratory Tract Diseases Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Stroke Urogenital Diseases Vascular Diseases Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastwood Clinic, Pietermaritzburg, KwaZulu-Natal, South Africa

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About this study

Control facilities Participants in control facilities will continue to receive usual care. Primary health care of long-term conditions is delivered free-at-point-of-care in public sector primary care facilities which includes the management of HIV, NCDs and mental health problems, according to South Africa's Ideal Clinic and Integrated Clinical Services Management model. This care model, which has combined the long-term care of HIV together with NCDs within each facility, has greatly enabled the feasibility of further interventions specifically addressing MLTCs and includes the Adult Primary Care (APC) or PACK clinical guidance. Patients attending these chronic services usually attend the same clinic regularly, 3 to 6-monthly for periodic monitoring of their chronic conditions. Chronic medication is collected monthly either at the facility (through fast-track queues), or through decentralised chronic medication dispensing systems which provide for collection from a range of sites including community venues (e.g. halls), wellness or adherence clubs, trailers, retail pharmacies (in KZN) or e-Lockers.

Intervention clinics

Participants in intervention clinics will continue with usual care as described for control clinics but in addition will receive the ENHANCE health systems intervention comprising tools and implementation strategies that have been co-developed with stakeholders through an iterative process, drawing on:

i. Evidence on the commonest MLTC combinations ii. Scoping reviews conducted on effectiveness of MLTCS interventions and systems barriers and enablers of person-centred care for MLTCs in LMICs iii. Provincial and district learning collaborative workshops with stakeholders from KZN and Western Cape.

iv. Clinical working groups with clinicians and health workers, a Guidance Oversight Board v. Input from our ENHANCE advocacy academy of 16 people living with MLTCs in the Western Cape and KZN

The intervention targets screening and early identification of other chronic conditions; improving follow-up and support for people with a new diagnosis, at risk of treatment failure (e.g. poorly controlled HIV or diabetes), and strengthen bi-directional referral pathways between the facility and community. Tools and implementation strategies will be layered into existing architecture of the chronic care system and support provision of more person-centred and empowering care across the treatment cascade.

Tools to support the implementation of the health systems intervention comprise:

  • An integrated clinical decision support tool for care of MLTCs drawing on PACK/ APC.
  • A range of patient-focussed materials to support condition, treatment, and systems (care-seeking) literacy (e.g., medication list, posters, scripts for health education talks)
  • A personal health diary (paper-based)

Implementation strategies include:

  • 1 facility team session to introduce the ENHANCE study to the whole team
  • 3 clinical sessions for nurses and doctors
  • 2 sessions for community health workers and health promoters
  • Maintenance sessions to keep the ENHANCE intervention going for at least 12 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 40 years or older
  • Receiving care for at least two of the following conditions, with at least one of the first five listed conditions being uncontrolled or patients indicated as struggling with the management of their condition:

i. HIV (Self-reported current treatment). ii. hypertension (Self-reported current treatment. iii. diabetes (Self-reported current treatment). iv. asthma (Self-reported current treatment). vi. depression (Self-reported current treatment). vii. previous myocardial infarction (self-reported). viii. previous stroke (self-reported history).

Exclusion criteria

  • Participants planning to relocate from either uMgungundlovu, KwaZulu-Natal, and Cape Metro in Western Cape, or changing their facilities during the period of the study.
  • Participants who are unable to give informed consent due to loss of capacity.
  • Participants self-reporting pregnancy
  • Participants who cannot communicate in English, isiXhosa, isiZulu, or Afrikaans.
  • Participants who are not willing to receive care for chronic conditions in their homes.

Treatment and study plan

ENHANCE intervention (health systems)

Other

The intervention tools include a consolidated clinical decision support tool, health education posters, waiting room talks, medication list for treatment literacy and a patient health diary. Training session are delivered at all intervention sites and include 1 facility team session to introduce the ENHANCE study to the whole team; 3 clinical sessions for nurses and doctors; 2 sessions for community health workers and health promoters; Maintenance sessions to keep the ENHANCE intervention going for at least 12 months

Primary outcomes

  1. Composite outcome: Diagnosis and treatment initiation for a new condition, intensification or change of treatment for a condition treated at enrolment, or improved control for a condition not optimally controlled at enrolment.

    Time frame: 12 months

    Number of participants who meet any of the following criteria during follow-up:

    • . Diagnosis and initiation of treatment during follow-up of one or more additional chronic conditions,
    • . Intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment, or,
    • . Improved control of at least one condition that was not optimally controlled at baseline, defined as follows: HIV - viral suppression (viral load <50 copies/mL); hypertension - systolic blood pressure<140 mmHg and diastolic blood pressure less than 90mmHg; diabetes - HbA1c <8%, asthma - Asthma Control Test score ≥16, depression - Patient Health Questionnaire 8 (PHQ-8) <10

Secondary outcomes

  1. Diagnosis and initiation of treatment during follow-up of one or more additional chronic conditions

    Time frame: 12 months

    The number of participants having a diagnosis and treatment initiation during follow-up of one or more additional chronic conditions

  2. Intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment

    Time frame: 12 months

    The number of participants with intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment

  3. Improved control of at least one condition that was not optimally controlled at baseline

    Time frame: 12 months

    The number of participants with improved control of at least one condition that was not optimally controlled at baseline, defined as follows: HIV - viral suppression (viral load <50 copies/mL); hypertension - systolic blood pressure<140 mmHg and diastolic blood pressure less than 90mmHg; diabetes - HbA1c <8%, asthma - Asthma Control Test score ≥16, depression - Patient Health Questionnaire 8 (PHQ-8) <10

  4. World Health Organisation Disability Assessment Schedule 2.0 score

    Time frame: 12 months

    Mean functional disability score assessed using the 12-item WHODAS-2.0 (World Health Organisation Disability Assessment Schedule 2.0) tool. The scores range from 0-100, with higher scores indicating more functional limitations/disability

  5. Health-related quality of life EuroQol 5-Dimension 5-Level score

    Time frame: 12 months

    Mean health-related quality of life score assessed using the EuroQol 5D-5L (EQ5D-5L). The EQ5D-5L score ranges from -0.493 (indicating the worst health state) to 1 (indicating the best health state

  6. Health-related quality of life visual analogue scale score

    Time frame: 12 months

    Mean self-reported health-related quality of life score assessed using a visual analogue scale (VAS). The VAS score ranges from 0-100, with higher scores indicating better health status.

  7. Patient Assessment of Chronic Illness Care

    Time frame: 12 months

    Mean Patient Assessment of Chronic Illness Care (PACIC) score. The score ranges from 1 - 5, with lower scores indicating worse satisfaction with chronic care and higher scores indicating more satisfaction

  8. Patient experience with treatment and self-management

    Time frame: 12 months

    Mean scores for patient experience with treatment and self-management (PETS), assessed using a shortened version of the PETS tool. The tool has no overall score and uses domain scores with different ranges. Lower scores indicate more difficulty, and higher scores indicate more ease.

  9. Patient Health Questionnaire-8 (PHQ-8) score

    Time frame: 12 months

    Mean scores for depressive symptoms assessed using the patient health questionnaire-8 (PHQ-8) tool. The score ranges from 0-24, with higher scores indicating worse depressive symptoms

  10. Social Support

    Time frame: 12 months

    Number of patients reporting having social support for their care and medical needs, and mean social support score

  11. Healthcare utilisation - Number of clinic visits

    Time frame: 12 months

    Number of clinic visits

  12. Healthcare utilisation - Number of hospital outpatient visits

    Time frame: 12 months

    Number of hospital outpatient visits

  13. Healthcare utilisation - hospital admissions

    Time frame: 12 months

    Number of hospital admissions

  14. Healthcare utilisation - hospital admission days

    Time frame: 12 months

    Number of hospital in-patient days

  15. Health care costs

    Time frame: 12 months

    The costs of accessing healthcare

Other outcomes

  1. Implementation

    Time frame: 12 months

    Reach, adoption and implementation, and maintenance of the ENHANCE intervention:

    • Exposure of PHC staff and patients to elements of the intervention and implementation strategy,
    • Integration of intervention components into care
    • Appropriateness of new diagnoses and treatment
    • Patient, clinician and CHW perceptions of the acceptability of the ENHANCE intervention and associated barriers and facilitators to its implementation

Sponsors and collaborators

Lead sponsor

University of KwaZulu

Other

Collaborators

  • King's College London
  • Medical Research Council, South Africa
  • University of Cape Town
  • University of East Anglia
  • University of Oxford

Registry information

Official study title

Effectiveness of a Health Systems Strengthening Intervention to Improve Detection, Treatment, and Control of Multiple Long-Term Conditions in Primary Health Care Facilities in the Western Cape and KwaZulu Natal, South Africa

Acronym: ENHANCE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Feb 24, 2026

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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