The Effect of a Family-dyad Partnership Program on Blood Pressure Control for People with Hypertension in China Rural Communities: A Randomised Controlled Trial

Hypertension is a major risk factor for cardio-cerebrovascular diseases and the related morbidities and mortality. The prevalence of hypertension ranges from 30%-45% globally. However, the percentage of patients with well-controlled hypertension, especially those living in rural areas in developing and developed countries, is relatively low (9.8%-19.4%) when compared with its global average and those in living urban areas. Multilevel (patient, provider, and health care system) and multicomponent (e.g., multidisciplinary team care, medication titration by physicians, and home blood pressure [BP] monitoring) intervention strategies are considered effective for the control of BP or its reduction to normal. However, health disparities in rural areas such as the underdeveloped health care system/service and inadequate number of health care providers limit the implementation of multilevel and multicomponent interventions.The family is an important source of social support for patients with hypertension in rural areas. Family care, defined as unpaid assistance to a patient by family in the patient's place of residence, has the potential to facilitate patient's adherence to recommended treatment regimens (e.g., medication adherence and lifestyle modification) in daily hypertension care at the home setting. A family carer is a member of one family with kinship, marital, or co-residence relationships involved in a patient's health care in everyday life. The concept of family care intrinsically involves the patients and their family carers (i.e., the dyad) in close interactions and relationships. Evidently, patients and families can benefit from interventions involving family carers in the chronic illness care for their sick family members.However, for family members involved in illness care, the caregiving process can be stressful and which can negatively affect the relationship between hypertensive patients and their families, as well as their physical and psychological health. Family interventions for hypertension care need to emphasise the development of a healthy and an effective patient-family partnership in illness management. In order to address the above-mentioned knowledge gaps, this PhD study with three phases aimed to develop and test a patient-family (carer) partnership intervention for hypertensive patients and their family carers in rural communities of mainland China.In this study's Phase I, a systematic review was conducted to examine the effectiveness of psychoeducational intervention for family carers or family dyads. Results of this review indicated that psychoeducational interventions could benefit hypertensive patients in terms of better controlling their BP. The pooled results indicated a significant reduction in systolic blood pressure (SBP) (mean difference: -8.39 mmHg, p < 0.01) and diastolic blood pressure (DBP) (mean difference: -5.35 mmHg, p < 0.01) at not more than three-month post-intervention (T2). These results further indicated medium-effect sizes on reductions in SBP (standardised mean difference: -0.59, p < 0.01) and DBP (standardised mean difference: -0.57, p < 0.01). Family dyad-oriented psychoeducation using a mixed teaching approach (i.e., combining didactic and participatory learning to improve the family-dyad partnership) could be a promising option of intervention for hypertension management in rural areas.In this study's Phase II, the Dyadic Relationship Scale (DRS; with the patient and caregiver versions, denoted as DRS-patient and DRS-caregiver, respectively) was translated from English to simplified Chinese language. The psychometric properties of the Chinese versions were tested in 142 hypertensive patients and family carers living in a rural community in Hunan Province, China. A similar two-factor structure of the Chinese version of the DRS to the original English version was confirmed. Cronbach's α coefficients of the Chinese versions of DRS-patient and DRS-caregiver were 0.82 and 0.83, respectively. Test-retest reliability with intra-correlation coefficients were 0.97 and 0.96, respectively. The convergent validity of the Chinese version of DRS-patient (with the self-efficacy subscale of Hypertension Self-Care Profile) and DRS-caregiver (with the Zarit Burden Interview) was very satisfactory (Pearson's r = -0.70 and 0.79; both p < 0.001). Significant differences in the mean scores of the Chinese versions of DRS-patient (t = -8.10, p < 0.001) and DRS-caregiver (t = -9.15, p < 0.001) were observed between the groups of hypertensive patients and normal BP counterparts. The Chinese version of the DRS was validated and found useful to assess the dyadic-relationship quality of Chinese hypertensive patients and their family carers in the main study.In this study's Phase III, a 10-week patient-family (carer) partnership intervention (PFPI) was developed based on the findings of the systematic review in Phase Ⅰ, concepts of the Shared Care Model, and recommendations from the national and international guidelines for hypertension management. A randomised controlled trial was conducted to examine the effects of PFPI on the outcomes for hypertension patients and their family carers in rural communities of mainland China. A total of 110 family dyads were randomly recruited from two village clinics and randomly allocated to the intervention group (n = 55) or a control group (n = 55). Family dyads in the control group received usual care delivered by the village doctors. In addition to the usual care, family dyads in the intervention group received the individual-based, five-session PFPI delivered biweekly by the researcher during home visits over 10 weeks. The primary outcomes included systolic BP, diastolic BP, and the proportion of patients with normal controlled BP (defined as < 140/90 mmHg for ordinary adults; < 150/90 mmHg for patients aged 65 years or above; and < 130/80 mmHg for patients with diabetes or chronic kidney disease with albuminuria). Data were collected at the baseline (T0), one-month (T1), and three-month post-intervention (T2). Generalised Estimating Equation model was adopted to test the study hypotheses on all study outcomes.Among the 55 family dyads in the intervention group, 54 completed the five-session PFPI; whereas, 103 of 110 (93.64%) participants completed three outcome measurements. Hypertensive patients in the intervention group had a greater reduction in SBP by 10.10 mmHg (p < 0.001) and DBP by 4.66 mmHg (p = 0.02), respectively, compared with the control group at T2. The proportion of patients with normal BP for the intervention group was significantly larger at T2 compared with the control group (p = 0.01).Compared with the control group, the patients in the intervention group demonstrated significant improvements at T1 and T2 in dyadic relationship (both p < 0.01), self-care (both p < 0.001), antihypertensive drug-titration rate (p = 0.01 and < 0.001, respectively), anxiety symptoms (both p = 0.01), and health-related quality of life (EuroQol five-dimensional-five-level: p = 0.003 and 0.01, respectively; EQ visual analogue scale: p < 0.001 and = 0.001, respectively), as well as positive changes in self-efficacy (p = 0.03) at T2.At T1 and T2, the PFPI also had significant positive effects on family carer's dyadic relationship (p = 0.04 and 0.049, respectively), and health-related quality of life (EuroQol five-dimensional-five-level: p = 0.03 and 0.02, respectively). The anxiety symptoms (p = 0.02) and health-related quality of life (EQ visual analogue scale: p = 0.04) at T1 were significantly greater improved in the intervention group compared with the control group.In conclusion, PFPI can improve hypertensive patients' BP control and patients' and family carers' dyadic-relationship quality and mental health at short-to-medium term follow-ups. This PhD study provided evidence and direction to support health care providers to develop and implement PFPI for hypertension care in rural areas, especially the communities in mainland China studied/reported in this thesis.家庭照顧者方面，與對照組比較，在T1和T2時，干預組家庭照顧者的合作關係 (p = 0.04和0.049) 以及健康相關生活質量 (p = 0.03和0.02 )有顯著提高;焦慮症狀 (p = 0.02) 僅在T1時有顯著改善；抑鬱症狀僅在T2時有顯著改善 (p = 0.049)。總而言之，高血壓患者與家庭照顧者合作關係干預措施可以有效改善高血壓患者的血壓控制以及患者及其家庭照顧者的合作關係和心理健康。這項博士課題的研究發現，為將高血壓患者與家庭照顧者合作關係干預措施融入現有的農村基層高血壓管理方案提供了證據和方向。高血壓是心腦血管疾病發病率和死亡率的主要危險因素。全球高血壓的患病率為30-45％, 而且高血壓控制率比例較低（9.8% 19.4%）。無論在發展中國家還是發達國家，農村地區的高血壓患者的血壓控制率均低於城市地區。綜合性干預策略（例如，同時針對患者，衛生服務提供者和醫療保健系統的幹預，並結合多學科合作及家庭血壓監測）被認為是最有效方法血壓管理方法。但是，相對城市社區而言，農村地區基層衛生服務體系欠發達，衛生服務人員不足等缺陷，可能會限制此類綜合性高血壓管理措施的實施。家庭是農村地區高血壓患者社會支持的重要來源。家庭照顧是指為患者在其住所內由家庭成員提供的無償幫助。家庭照顧可協助患者在日常高血壓管理中執行醫生推薦的治療方案（例如，堅持用藥和形成健康的生活方式）。家庭照顧者可以是具有親屬，婚姻或同居關係的家庭成員。家庭照顧活動促使患者及其家庭照顧者建立起一種緊密的合作關係。此類合作關係一方面可以使患者和照顧者受益，例如，提高服藥依從性和形成健康生活方式。另一方面，在合作進行行為改變的過程中，兩者缺乏有效溝通和合作的技能，導致家庭照顧者和患者都可能會有壓力，以及想法、觀念和行为上的衝突。這可對高血壓患者與照顧者之間的關係以及他們的身心健康產生負面影響。因此，高血壓管理的家庭照顧方案需要強調在疾病管理方面建立健康的患者與家庭照顧者合作夥伴關係。因此，本博士課題旨在形成一種能提高中國大陸農村社區的高血壓患者及其家庭照顧者合作夥伴關係的干預措施，並評價其效果。在博士課題的第一階段，進行了系統回顧和薈萃分析，以探討基於家庭照顧的心理教育干預策略對高血壓患者及其家屬的影響。結果表明，基於家庭照顧的心理教育干預措施具有有效管理高血壓的潛力。第二階段，翻譯了中文版患者與照顧者合作關係量表，並進行了信度和效度測試。對142對高血壓患者和家庭照顧者的調查結果表明，中文版患者與照顧者合作關係量表具有良好的心理測量特性，可用於評估第三階段研究中的中國高血壓患者及其家庭照顧者的合作關係。本博士課題的第三階段為開發和評價高血壓患者與家庭照顧者合作關係干預項目。根據上述系統回顧的結果，合作照顧模型（Shared Care Model）理論以及中國和國際高血壓管理指南的建議，形成了為期10週的高血壓患者與家庭照顧者合作關係干預項目。本研究採用隨機對照試驗設計的方法驗證了該干預措施的有效性。將110對中國大陸農村社區中的高血壓患者及其家庭照顧者隨機分配到干預組（55對）和對照組（55對）。對照組中的研究對象接受了鄉村醫生的常規家庭隨訪服務。除此之外，干預組的研究對象還接受了每兩週一次（共5次）的高血壓患者與家庭照顧者合作關係干預內容包括高血壓管理知識教育(1次)，以及溝通、決策和互惠技能培訓（4次）。主要研究指標為收縮壓和舒張壓以及各組研究對象中血壓合格者比例(例如，普通成年人血壓 < 140/90 mmHg; 65歲及以上老年人 < 150/90 mmHg；糖尿病患者和有尿蛋白的腎病患者 < 130/80 mmHg)。二級指標包括患者的自我管理和自我效能，以及患者和照顧者的合作關係、抑鬱症狀、焦慮症狀和健康相關生活質量。資料收集發生在基線(T0)，干預結束後一個月（T1）和干預結束後三個月（T2）。採用廣義估計方程模型對研究結果進行統計分析。研究結果表明，干預組的55對研究對象中有54對完整接受了高血壓患者與家庭照顧者合作關係干預措施。110對研究對象中有103對(93.64％)完成了全部數據收集。與對照組相比，干預組的高血壓患者收縮壓進一步降低了10.10 mmHg (p < 0.001)，舒張壓進一步降低了4.66 mmHg (p = 0.02)。在T2時，干預組血壓正常患者比例高於對照組 (p = 0.03)。此外，與對照組比較，在T1和T2時，干預組的高血壓患者在合作關係 (p 均< 0.01)，自我護理 (p 均 < 0.001)，降壓藥調整 (p = 0.01和< 0.001)，焦慮症狀 (p 均 = 0.01) 以及健康相關生活質量（p 均 < 0.05）有顯著的積極改變；而自我效能 (p = 0.03) 僅在T2時有顯著改變。ZENG, Dejian.Ph.D. Chinese University of Hong Kong 2021.Includes bibliographical references (leaves )Abstracts in English and Chinese.Title from PDF title page (viewed on ...