- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02087137
Functional Impact of a Memory Intervention Program
Normal aging is associated with decline in some aspects of memory, and this can be a risk factor for reductions in everyday functioning. The Baycrest Memory and Aging Program teaches positive adaptation to age-related memory changes, including strategies for minimizing the everyday impact of normal memory change and positive lifestyle change to maximize brain health. Prior research has shown that the Memory and Aging program is effective in increasing participants' knowledge about memory, use of memory strategies, and confidence in memory function, as well as adoption of healthier lifestyle practices and reduction in intention to use unneeded health care resources.
Although not one of the stated goals of the program, informal feedback from participants suggests that the educational content and skills training in the Memory and Aging Program has led some participants to change behaviours in ways that lead to significant improvements in their everyday functioning. For example, graduating participants often volunteer examples of how they have applied what they have learned to succeed in everyday memory tasks such as learning a new name or keeping track of future plans. Based on this participant feedback, it is hypothesized that the knowledge, skills, and confidence gained by Memory and Aging Program participants may lead to positive behaviour changes that, in turn, lead to improved everyday functioning. The present study will test this hypothesis using a randomized controlled pretest-posttest design.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M6A 2E1
- Baycrest
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 50-90
- Available to participate in all testing and intervention sessions (located in Toronto, Canada)
Exclusion Criteria:
- health conditions with major effects on cognition, including a current or previous history of stroke, brain surgery, or diagnosed neurological disorder
- dependence in instrumental activities of daily living
- cognitive impairment, defined as performance below cutoff for cognitive impairment on a standardized cognitive test, the Telephone Interview for Cognitive Status (Brandt, Spencer, & Folstein, 1988).
- affective impairment, defined as performance below cutoff for depression on standardized depression screen, the Geriatric Depression Scale (Yesavage et al., 1983)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Memory and Aging Program
The Memory and Aging Program intervention consists of five 2-hour sessions conducted over five consecutive weeks.
The content of the program includes: (a) the provision of factual information (i.e., about memory, age-related memory changes, lifestyle factors affecting memory, and memory strategies) in an informal lecture format; and (b) memory intervention (i.e., practice and application of several evidence-based memory strategies) in a hands-on interactive format.
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Sin intervención: Wait-list Control
Participants randomized to the wait-list control group will receive no intervention following randomization.
They will be offered the intervention immediately following completion of the week 14 outcome testing session.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Change from baseline in healthy lifestyle behaviours as measured by Health Promoting Lifestyle Profile II (Walker, Sechrist, & Pender, 1987)
Periodo de tiempo: Baseline, Week 8, week 14
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Baseline, Week 8, week 14
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Change from baseline in memory strategy use as measured by the Memory Strategy Toolbox (modified from Troyer, 2001)
Periodo de tiempo: Baseline, Week 8, week 14
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Baseline, Week 8, week 14
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Attainment of individualized goals for (a) lifestyle change, (b) memory strategy use, and (c) functional outcomes of memory strategy use as measured by Goal Attainment Scaling (Gordon, Powell, & Rockwood, 2000; Kiresuk, Smith, & Cardillo, 1994)
Periodo de tiempo: Baseline, Week 8, week 14
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Baseline, Week 8, week 14
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in positive and negative affect as measured by Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988)
Periodo de tiempo: Baseline, Week 8, week 14
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Baseline, Week 8, week 14
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Change in general health status as measured by the RAND 36-Item Short-Form Health Survey (Ware & Sherbourne, 1992).
Periodo de tiempo: Baseline, Week 8, week 14
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Baseline, Week 8, week 14
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General Self-Efficacy Scale (Schwarzer & Jerusalem, 1995)
Periodo de tiempo: Baseline, Week 8, week 14
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Baseline, Week 8, week 14
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Prospective and Retrospective Memory Questionnaire (Smith, Della Sala, Logie, & Maylor, 2000)
Periodo de tiempo: Baseline, Week 8, week 14
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Baseline, Week 8, week 14
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Self-report health status, lifestyle changes, attitudes about aging
Periodo de tiempo: Baseline, Week 8, week 14
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Baseline, Week 8, week 14
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
---|---|
Change in memory knowledge as measured by Memory knowledge quiz (modified from Troyer, 2001).
Periodo de tiempo: Baseline, Week 8, week 14
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Baseline, Week 8, week 14
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Change in self-perceived memory as measured by Multifactorial Metamemory Questionnaire (Troyer & Rich, 2002)
Periodo de tiempo: Baseline, 8 weeks, 14 weeks
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Baseline, 8 weeks, 14 weeks
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Change in prospective memory function (Prospective telephone-call task, Troyer, 2001; actual week, Rendell & Craik, 2001)
Periodo de tiempo: Baseline, 8 weeks, 14 weeks
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Baseline, 8 weeks, 14 weeks
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Change in name learning (Name-learning task, based on Troyer, Häfliger, Cadieux, & Craik, 2006)
Periodo de tiempo: Baseline, 8 weeks, 14 weeks
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Baseline, 8 weeks, 14 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Susan Vandermorris, PhD, Baycrest
Publicaciones y enlaces útiles
Publicaciones Generales
- Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
- Troyer AK, Rich JB. Psychometric properties of a new metamemory questionnaire for older adults. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P19-27. doi: 10.1093/geronb/57.1.p19.
- Brandt, J., Spencer, M., & Folstein, M. (1988). The Telephone Interview for Cognitive Status. Neuropsychiatry, Neuropsychology, & Behavioral Neurology, 1(2), 111-117.
- Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.
- Troyer AK, Hafliger A, Cadieux MJ, Craik FI. Name and face learning in older adults: effects of level of processing, self-generation, and intention to learn. J Gerontol B Psychol Sci Soc Sci. 2006 Mar;61(2):P67-74. doi: 10.1093/geronb/61.2.p67.
- Gordon J, Rockwood K, Powell C. Assessing patients' views of clinical changes. JAMA. 2000 Apr 12;283(14):1824-5. No abstract available.
- Kiresuk, T. J., Smith, A., & Cardillo, J. E. (1994). Goal attainment scaling: Applications, theory, and measurement. Hillsdale, NJ: Lawrence Erlbaum Associates.
- Troyer, A. K. (2001). Improving memory knowledge, satisfaction, and functioning via an education and intervention program for older adults. Aging, Neuropsychology, and Cognition, 8(4), 256-268.
- Vandermorris S, Au A, Gardner S, Troyer AK. Initiation and maintenance of behaviour change to support memory and brain health in older adults: A randomized controlled trial. Neuropsychol Rehabil. 2022 May;32(4):611-628. doi: 10.1080/09602011.2020.1841656. Epub 2020 Nov 17.
- Herdman KA, Vandermorris S, Davidson S, Au A, Troyer AK. Comparable achievement of client-identified, self-rated goals in intervention and no-intervention groups: reevaluating the use of Goal Attainment Scaling as an outcome measure. Neuropsychol Rehabil. 2019 Dec;29(10):1600-1610. doi: 10.1080/09602011.2018.1432490. Epub 2018 Feb 12.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 14-21
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