Feasibility of a Person-centered Nursing Intervention on Adherence and Control in Patients With Arterial Hypertension and Diabetes Mellitus. (CERCANO pilot)
Feasibility of a Person-centered Nursing Intervention on Adherence and Control in Patients With Arterial Hypertension and Diabetes Mellitus. CERCANO Pilot Trial.
Background. Approximately 80% of people with type 2 diabetes mellitus (DM) or arterial hypertension (HTN) do not achieve adequate disease control.
Objective. To evaluate the feasibility of a research study assessing the impact of an educational and nursing counseling intervention with a person-centered care (PCC) approach to improve adherence and control in patients with arterial hypertension and diabetes mellitus in Colombia.
Methods. A pilot randomized controlled clinical trial will be conducted. Adults with DM or HTN enrolled in cardiovascular or metabolic risk programs will be included. A total of 100-200 patients is expected to be recruited. The intervention group will receive counseling and education tailored to their preferences following the PCC approach, while the control group will receive standard care according to the program they belong to. Follow-up will last 6 months, and the primary outcomes to be measured in both groups are: medication adherence, DM control (HbA1c at target levels, change in HbA1c), and HTN control (SBP and DBP at target levels, changes in SBP and DBP).
Results. The findings of this study will provide insight into the feasibility of conducting larger-scale studies to evaluate the effectiveness of PCC-based interventions in Colombia.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Skarlet Marcell Vásquez, RN, MSc
- 電話番号：573012850414
- メール：svasquez196@unab.edu.co
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults (18 years or older).
- Diagnosis of type 2 diabetes mellitus (DM) or arterial hypertension (HTN) (or both), documented in the medical record.
- Prescription of pharmacological treatment for the condition.
- Enrollment in a cardiovascular or metabolic risk program and scheduled for a medical follow-up visit within the next 3 to 6 months.
Exclusion Criteria:
- Mental disorders that impair autonomy or understanding of the interventions.
- Congestive heart failure, ischemic or valvular heart disease, end-stage renal disease requiring dialysis, chemotherapy treatment, autoimmune diseases, recent hospitalization due to disease decompensation (within the last month), or any other condition preventing the patient from receiving general health recommendations according to their primary diagnosis.
- Physical limitations such as quadriplegia, total loss of motor function, or contraindications to physical activity as indicated by medical prescription.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Person-centered nursing intervention
A nursing consultation to engage with the patient around what matters to them and co-create a goal-oriented educationand counseling plan. The individualized plan with educational and counseling interventions will include up to six content domains:
The educational and counseling content will be based on the general recommendations for the management of HTN and DM included in the clinical practice guidelines of the Colombian Ministry of Health and Social Protection, respectively. Patients will be able to choose the domains of counseling according to their interests and preferences, as well as the modality and frequency through which they wish to receive the intervention. |
A nursing consultation to engage with the patient around what matters to them and co-create a goal-oriented education plan.
The individualized plan with educational and counseling interventions will include up to six content domains: 1. Disease pathophysiology and treatment 2. Healthy diet and nutrition 3. Physical activity 4. Medication use 5. Health monitoring and follow-up 6. Prevention, detection, and management of complications The educational and counseling content will be based on the general recommendations for the management of HTN and DM included in the clinical practice guidelines of the Colombian Ministry of Health and Social Protection, respectively.
Patients will be able to choose the domains of counseling according to their interests and preferences, as well as the modality and frequency through which they wish to receive the intervention.
|
|
介入なし：Usual care
Patients assigned to the control group will receive usual care interventions provided within the cardiovascular/metabolic risk programs to which they belong at each participating healthcare institution.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disease control
時間枠：From enrollment to the end of intervention at 6 months
|
Disease control will be defined as:
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From enrollment to the end of intervention at 6 months
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Medication adherence
時間枠：From enrollment to the end of intervention at 6 months
|
Medication adherence: Rate of patients with medication adherence.
Medication adherence will be measured using the Morisky-Green questionnaire (short version, 4 items), which has been validated in previous studies in populations with chronic conditions in the Colombian context.
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From enrollment to the end of intervention at 6 months
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 35046441 (レジストリ識別子：ID-UNAB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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