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

NCT06248190

CompletedNA

Sponsor: University of KwaZulu

Conditions: HIV Infections, Hypertension, Diabetes Mellitus, Asthma, Depression

Interventions: ENHANCE intervention (health systems)

Countries: South Africa

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.

Eligibility overview

Sex: ALL

Age: 40 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (32)
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Pietermaritzburg, KwaZulu-Natal, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • Cape Town, Western Cape, South Africa
  • + 2 more on CT.gov