Intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer
Multimodal Intervention to Reduce Unwanted Loneliness and Improve the Living With Process Among Family Caregivers of People With Alzheimer's Disease
調査の概要
状態
詳細な説明
This project proposes a multimodal and interdisciplinary intervention aimed at alleviating or reducing unwanted loneliness and improving the living with process of family caregivers of individuals with Alzheimer's disease (AD). In doing so, it seeks to enhance their health and overall quality of life. The intervention will include activities such as health education, physical activity and music therapy.
The interdisciplinary team will also incorporate citizen participation, specifically through the involvement of an individual who has previously been a family caregiver of a person with AD. There is a growing body of evidence indicating that citizen participation in healthcare is highly advisable, as it is expected to improve the quality and relevance of outcomes.
This is a prospective, longitudinal, analytical, and experimental study.
The proposed study will involve different groups and the program will last for a total of 12 weeks. The program will include the following activities:
Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions.
Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, Alzheimer disease, among others.
Music therapy workshops. Through listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance, the enjoyment and expression of feelings will be encouraged. There will be 1 session per week. Total 12 sessions
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：Silvia Corchón, PhD
- 電話番号：0034 963864182
- メール：Silvia.Corchon@uv.es
研究場所
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Valencia
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Valencia、Valencia、スペイン、46010
- University of Valencia
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Family caregivers of people with Alzheimer's disease (AD).
- Primary family caregivers who live with the person with AD.
- The person with AD must be enrolled in one of the adult day care centers where the study is conducted.
- Ability to communicate in Spanish and/or Valencian.
Exclusion Criteria:
- Presence of moderate or severe cognitive impairment, mental disorder, significant sensory impairment, disabling chronic illness, or any medical condition that contraindicates participation in any of the study activities.
- Family caregivers of institutionalized individuals.
- Family caregivers of people with AD who have died.
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：ヘルスサービス研究
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
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：Experimental group
The multimodal interventions includes:
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The multimodal intervention will include these activities:
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介入なし：No intervention group
This group will receive the ussual care in the day centers for familiar caregiver
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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 |
|---|---|---|
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Score on the Jong Gierveld Lonelinss Scale
時間枠：From the beginning of the enrollement until the end of the intervention at 12 weeks
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Loneliness Scale Social isolation will be measured with the Jong Gierveld Loneliness Scale. The final score is the total score for the 11 items, with the lowest possible score being 0 (no loneliness) and the highest being 11 (severe loneliness). Three categories have been proposed based on the score: a score of 0-2 points = no loneliness; a score of 3-8 points = moderate loneliness; and a score of 9-11 points = severe loneliness. |
From the beginning of the enrollement until the end of the intervention at 12 weeks
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Living with chronic conditions from the family perspective
時間枠：From the enrollment to the end of the intervention at 12 weeks
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Living with LTCs scale from the perspective of the family caregiver (EC- PC- Fam).
This is an instrument adapted from the original EC- PC.29-31
The adaptation process of the instrument and prior pilot study have been previously described in detail.23
The validated version has 31 items and 5 domains: (1) acceptance, (2) coping, (3) self- management, (4) integration and (5) adaptation.
All the items follow a Likert scale of 5 points answer system, from never or none (0) to always and much (4), except for the items from the acceptance domain, which must be inverted to obtain results such as never or none (4) or always or much (0).
The scores range from 0 to 155, with a higher score indicating more positive living with LTCs.
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From the enrollment to the end of the intervention at 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Score in Goldberg Anxiety and Depression Scale.
時間枠：From enrollement until the end of the intervention ar 12 weeks
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The symptoms of anxiety and depression will be measured with the Goldberg Anxiety and Depression Scale. This is a questionnaire that discriminates between the diagnosis of anxiety and depression and measures their retrospective intensities. It consists of two subscales: one for anxiety and one for depression. Each subscale is composed of 9 dichotomous response items (YES or NO) to determine whether the subject has had any of the indicated symptoms in the last two weeks. The cut-off points are 4 or more items or affirmative responses for the anxiety scale and 2 or more for the depression scale. The higher the score, the greater the severity of the problem, with a maximum possible score of 9 points for each subscale. |
From enrollement until the end of the intervention ar 12 weeks
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The score in the EuroQQL-5
時間枠：From enrollement until the end of the intervention at 12 weeks
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The EuroQOL- 5 Dimensions 5- Level version (EQ- 5D- 5L) is an instrument designed to generically measure HRQOL, which can be used by both a healthy population and an individual with pathologies.
The instrument developed by the EUROQOL group32 has been validated in many countries, including Spain.33 34 Different versions can be found, and in the present study, the EQ- 5D- 5L was selected due to the increase in the specificity of the responses as compared with the EQ- 5D- 3L.
It is a self- administered instrument in which individuals assess their own health, first in a descriptive manner for each of the dimensions (mobility, personal care, everyday activities, pain/ discomfort and anxiety/depression), with five levels, from 0 to 5, and then with a more general Visual Analogical Scale.
For the Spanish context, the psycho metric properties of the EQ- 5D- 5L scale were analysed in patients35 with the results indicating a reliability of 0.86.
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From enrollement until the end of the intervention at 12 weeks
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Score in Zarit Test for caregiver burden
時間枠：From enrollement until the end of the intervention at 12 weeks
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Zarit test: This scale is included to verify the external validity (divergent validity) of the EC- PC- Fam.
This scale, originally named Caregiver Burden Interview, is designed to assess the burden of caregivers of indi viduals with dementia, from the general theory of the items39.
It has 22 items that evaluate the negative repercussions on specific areas of daily life associated with caregiving: physical health, psychological health, social activities and economic resources.
As opposed to the original, the version validated in Spain40 includes a 5- point Likert scale, for a total score that ranges from 22 to 110.
In this study, different cut- off points were proposed: from 22 to 46, without burden; from 47 to 55, with burden and from 56 to 110, intense burden.
The scale obtained an internal consistency of 0.91 and test-retest reliability of 0.96.
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From enrollement until the end of the intervention at 12 weeks
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Marin-Maicas P, Portillo MC, Corchon S, Ambrosio L. Methodological Proposal for the Adaptation of the Living with Long-Term Conditions Scale to the Family Caregiver. Nurs Rep. 2024 Feb 27;14(1):532-544. doi: 10.3390/nursrep14010041.
- Mafla-Espana MA, Corchon S, Jimeno-de Pedro P, Ibanez-Del Valle V, Cauli O. Social and Mental Health Factors Involved in the Severity of Loneliness in Older Individuals in a Spanish Rural Area. Nurs Rep. 2024 Nov 29;14(4):3737-3753. doi: 10.3390/nursrep14040273.
- Marin-Maicas P, Ambrosio L, Corchon S, Gonzalez-Moreno J, Portillo MC. Living with long-term conditions: validation of a new instrument for family caregivers in a Spanish-speaking population. BMJ Open. 2024 Sep 20;14(9):e088773. doi: 10.1136/bmjopen-2024-088773.
- Sanchez-Martinez V, Cauli O, Corchon S. Long-Term Caregiving Impact and Self-Care Strategies in Family Caregivers of People with Neuropsychiatric Disorders: A Mixed-Method Study. Diseases. 2024 Nov 14;12(11):292. doi: 10.3390/diseases12110292.
- Marin-Maicas P, Corchon S, Ambrosio L, Portillo MC. Living with Long Term Conditions from the Perspective of Family Caregivers. A Scoping Review and Narrative Synthesis. Int J Environ Res Public Health. 2021 Jul 8;18(14):7294. doi: 10.3390/ijerph18147294.
- Ibanez-Del Valle V, Corchon S, Zaharia G, Cauli O. Social and Emotional Loneliness in Older Community Dwelling-Individuals: The Role of Socio-Demographics. Int J Environ Res Public Health. 2022 Dec 10;19(24):16622. doi: 10.3390/ijerph192416622.
- Zaharia G, Ibanez-Del Valle V, Cauli O, Corchon S. The Long-Lasting Effect of Multidisciplinary Interventions for Emotional and Social Loneliness in Older Community-Dwelling Individuals: A Systematic Review. Nurs Rep. 2024 Dec 6;14(4):3847-3863. doi: 10.3390/nursrep14040281.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
家族介護者の臨床試験
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Simon Fraser UniversityUniversity of British Columbia; McMaster University; University of Victoria; Public Health Agency... と他の協力者完了