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

NCT06248190 | Completed DMC

• 3 other identifiers: 686/2022201816BREC/00005033/2022
• Study Type: interventional
• Target: 1,837
• Locations: 1 country
• Sites: 32

Brief Summary

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. 1.To test and estimate the effect of the intervention in people with MLTCs attending
2. 2.To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance.
3. 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.

Conditions

Myocardial Infarction; HIV Infections; Hypertension; Diabetes Mellitus; Asthma; Depression; Stroke

Keywords

Multiple Chronic Conditions; Person Centered Care; Health Systems Intervention

Outcome Measures

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.

  Number of participants who meet any of the following criteria during follow-up: 1. . Diagnosis and initiation of treatment 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, or, 3. . 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

  12 months

Secondary Outcomes (15)

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

  12 months

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

  12 months

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

  12 months

• World Health Organisation Disability Assessment Schedule 2.0 score

  12 months

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

  12 months

Other Outcomes (1)

• Implementation

  12 months

Study Arms (2)

Intervention

OTHER

1. Treatment literacy in chronic condition waiting rooms/pick-up points (posters, health promotion talks) 2. 1-2 longer consultations with ENHANCE guide trained clinician 3. Treatment literacy event - a contact between a CHW and a person with MLTC in their home (hopefully with carer), at 2 weeks and 4 weeks, using Health Diary 4. Referrals to additional adherence counselling if necessary

Other: ENHANCE intervention (health systems)

Control

NO INTERVENTION

Usual care at primary health care clinic, which includes consultation with a clinician using the PACK/APC guide. No additional support is usually provided for care of MLTCs.

Interventions

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

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (32)

Eastwood Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Esigodini Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Gcumisa Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Gomane Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Howick Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Impilwenhle Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Injabulo Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Mafatini Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Mphophomeni Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Ndaleni Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Northdale Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Pata Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Richmond Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Songonzima Clinic

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Willowfontein CHC

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Delft CHC

Cape Town, Western Cape, 7700, South Africa

Location

Dr Abdurahman CHC

Cape Town, Western Cape, 7700, South Africa

Location

DuNoon CHC

Cape Town, Western Cape, 7700, South Africa

Location

Durbanville CHC

Cape Town, Western Cape, 7700, South Africa

Location

Elsies CHC

Cape Town, Western Cape, 7700, South Africa

Location

Gugulethu CHC

Cape Town, Western Cape, 7700, South Africa

Location

Gustrouw CDC

Cape Town, Western Cape, 7700, South Africa

Location

Hanover Park CHC

Cape Town, Western Cape, 7700, South Africa

Location

Heideveld CHC

Cape Town, Western Cape, 7700, South Africa

Location

Kleinvlei CHC

Cape Town, Western Cape, 7700, South Africa

Location

Kraaifontein CHC

Cape Town, Western Cape, 7700, South Africa

Location

Macassar CDC

Cape Town, Western Cape, 7700, South Africa

Location

Michael M

Cape Town, Western Cape, 7700, South Africa

Location

Mitchells Plain CHC

Cape Town, Western Cape, 7700, South Africa

Location

Retreat CHC

Cape Town, Western Cape, 7700, South Africa

Location

Vanguard CHC

Cape Town, Western Cape, 7700, South Africa

Location

Caluza Clinic

Pietermaritzburg, South Africa

Location

Related Publications (10)

• Peer N, Uthman OA, Kengne AP. Rising prevalence, and improved but suboptimal management, of hypertension in South Africa: A comparison of two national surveys. Glob Epidemiol. 2021 Sep 10;3:100063. doi: 10.1016/j.gloepi.2021.100063. eCollection 2021 Nov.

  PMID: 37635713 BACKGROUND

• Nguyen H, Manolova G, Daskalopoulou C, Vitoratou S, Prince M, Prina AM. Prevalence of multimorbidity in community settings: A systematic review and meta-analysis of observational studies. J Comorb. 2019 Aug 22;9:2235042X19870934. doi: 10.1177/2235042X19870934. eCollection 2019 Jan-Dec.

  PMID: 31489279 BACKGROUND

• Hurst JR, Dickhaus J, Maulik PK, Miranda JJ, Pastakia SD, Soriano JB, Siddharthan T, Vedanthan R; GACD Multi-Morbidity Working Group. Global Alliance for Chronic Disease researchers' statement on multimorbidity. Lancet Glob Health. 2018 Dec;6(12):e1270-e1271. doi: 10.1016/S2214-109X(18)30391-7. No abstract available.

  PMID: 30420026 BACKGROUND

• Mayosi BM, Flisher AJ, Lalloo UG, Sitas F, Tollman SM, Bradshaw D. The burden of non-communicable diseases in South Africa. Lancet. 2009 Sep 12;374(9693):934-47. doi: 10.1016/S0140-6736(09)61087-4. Epub 2009 Aug 24.

  PMID: 19709736 BACKGROUND

• Oni T, Youngblood E, Boulle A, McGrath N, Wilkinson RJ, Levitt NS. Patterns of HIV, TB, and non-communicable disease multi-morbidity in peri-urban South Africa- a cross sectional study. BMC Infect Dis. 2015 Jan 17;15:20. doi: 10.1186/s12879-015-0750-1.

  PMID: 25595711 BACKGROUND

• Gouda HN, Charlson F, Sorsdahl K, Ahmadzada S, Ferrari AJ, Erskine H, Leung J, Santamauro D, Lund C, Aminde LN, Mayosi BM, Kengne AP, Harris M, Achoki T, Wiysonge CS, Stein DJ, Whiteford H. Burden of non-communicable diseases in sub-Saharan Africa, 1990-2017: results from the Global Burden of Disease Study 2017. Lancet Glob Health. 2019 Oct;7(10):e1375-e1387. doi: 10.1016/S2214-109X(19)30374-2.

  PMID: 31537368 BACKGROUND

• Kamkuemah M, Gausi B, Oni T. Missed opportunities for NCD multimorbidity prevention in adolescents and youth living with HIV in urban South Africa. BMC Public Health. 2020 Jun 1;20(1):821. doi: 10.1186/s12889-020-08921-0.

  PMID: 32487118 BACKGROUND

• Herman AA, Stein DJ, Seedat S, Heeringa SG, Moomal H, Williams DR. The South African Stress and Health (SASH) study: 12-month and lifetime prevalence of common mental disorders. S Afr Med J. 2009 May;99(5 Pt 2):339-44.

  PMID: 19588796 BACKGROUND

• COVID-19 Mental Disorders Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. Lancet. 2021 Nov 6;398(10312):1700-1712. doi: 10.1016/S0140-6736(21)02143-7. Epub 2021 Oct 8.

  PMID: 34634250 BACKGROUND

• Roomaney RA, van Wyk B, Turawa EB, Pillay-van Wyk V. Multimorbidity in South Africa: a systematic review of prevalence studies. BMJ Open. 2021 Oct 6;11(10):e048676. doi: 10.1136/bmjopen-2021-048676.

  PMID: 34615675 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Hypertension; Diabetes Mellitus; Asthma; Depression; Myocardial Infarction; Stroke; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

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

Study Officials

• Lara Fairall, PhD

  King's College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Centre for Rural Health

Model Details: This study will be a type 2 hybrid trial, testing the effect of the intervention in improving clinical outcomes, and also testing and observing the effects of the intervention on implementation processes and outcomes using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. The trial will be a cluster randomised parallel arm trial with embedded process evaluation.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 8, 2024
• Study Start: September 19, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

ZA (32)