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Randomized Controlled Trial
. 2014 Apr 27:15:143.
doi: 10.1186/1745-6215-15-143.

Optimizing linkage and retention to hypertension care in rural Kenya (LARK hypertension study): study protocol for a randomized controlled trial

Rajesh Vedanthan  1 , Jemima H Kamano, Violet Naanyu, Allison K Delong, Martin C Were, Eric A Finkelstein, Diana Menya, Constantine O Akwanalo, Gerald S Bloomfield, Cynthia A Binanay, Eric J Velazquez, Joseph W Hogan, Carol R Horowitz, Thomas S Inui, Sylvester Kimaiyo, Valentin Fuster
Affiliations
Randomized Controlled Trial

Optimizing linkage and retention to hypertension care in rural Kenya (LARK hypertension study): study protocol for a randomized controlled trial

Rajesh Vedanthan et al. Trials. .

Abstract

Background: Hypertension is the leading global risk factor for mortality. Hypertension treatment and control rates are low worldwide, and delays in seeking care are associated with increased mortality. Thus, a critical component of hypertension management is to optimize linkage and retention to care.

Methods/design: This study investigates whether community health workers, equipped with a tailored behavioral communication strategy and smartphone technology, can increase linkage and retention of hypertensive individuals to a hypertension care program and significantly reduce blood pressure among them. The study will be conducted in the Kosirai and Turbo Divisions of western Kenya. An initial phase of qualitative inquiry will assess facilitators and barriers of linkage and retention to care using a modified Health Belief Model as a conceptual framework. Subsequently, we will conduct a cluster randomized controlled trial with three arms: 1) usual care (community health workers with the standard level of hypertension care training); 2) community health workers with an additional tailored behavioral communication strategy; and 3) community health workers with a tailored behavioral communication strategy who are also equipped with smartphone technology. The co-primary outcome measures are: 1) linkage to hypertension care, and 2) one-year change in systolic blood pressure among hypertensive individuals. Cost-effectiveness analysis will be conducted in terms of costs per unit decrease in blood pressure and costs per disability-adjusted life year gained.

Discussion: This study will provide evidence regarding the effectiveness and cost-effectiveness of strategies to optimize linkage and retention to hypertension care that can be applicable to non-communicable disease management in low- and middle-income countries.

Trial registration: This trial is registered with (NCT01844596) on 30 April 2013.

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Figures

Figure 1
Figure 1
AMPATH centers in Kenya numbered 1 to 35 and lettered A to Z; Kosirai and Turbo Divisions highlighted.
Figure 2
Figure 2
Modified Health Belief Model: personal (cognitive and emotional) and environmental factors.
Figure 3
Figure 3
Classification of participants in trial. BP = Blood Pressure; CHW-S = usual care arm; CHW-B = tailored behavioral communication strategy arm; CHW-BT = communication strategy and smartphone technology arm; CU- Community Unit.
Figure 4
Figure 4
Power to detect differences in the proportion of patients linked to care over a realistic range of ICC coefficients. Horizontal line is at 80% power. CHWs, community health workers; ICC, intraclass correlation; TBCS, CHWs with a tailored behavioral communication strategy; TBCS-ST, CHWs with a communication strategy and also equipped with smartphone technology; UC, usual care.
See this image and copyright information in PMC

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